Publications

Searched Practice: Food & Drug

"China's 1st Step Toward More Participation In Rulemaking," Law360 (9/6/2013)
Scott Cunningham Co-Author, Shaoyu Chen Co-Author, John Balzano Co-Author, Mingham Ji Co-Author

"CFDA Publishes Draft Rule on Administrative Procedure for Public Comment," Covington E-Alert (8/28/2013)
Shaoyu Chen Co-Author, Scott Cunningham Co-Author, John Balzano Co-Author, Mingham Ji Co-Author

"Recalls of FDA-Regulated Products - What You Need to Know," Covington E-Alert (8/19/2013)
Miriam Guggenheim Co-Author, Marialuisa Gallozzi Co-Author, Suzan Charlton Co-Author, Christopher Pruitt Co-Author

"FDA Updates Draft Guidance on Medical Foods," Covington E-Alert (8/16/2013)
Miriam Guggenheim Co-Author, Jeannie Perron Co-Author, MaryJoy Ballantyne Co-Author, Mingham Ji Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - July 2013," Covington E-Alert (8/12/2013)
Michael Labson Co-Author, Scott Danzis Co-Author, Saurabh Anand Co-Author

"FDA Releases Final Rule on "Gluten-Free" Labeling of Foods," Covington E-Alert (8/9/2013)
Miriam Guggenheim Co-Author, Jeannie Perron Co-Author, MaryJoy Ballantyne Co-Author, Colleen Kelly Co-Author

"FDA Extends Comment Period on FSMA Rules to November 15, 2013," Covington E-Alert (8/8/2013)
Miriam Guggenheim Co-Author, Jeannie Perron Co-Author, Christopher Pruitt Co-Author, Melissa Whittingham Co-Author

"Regulation of Mobile Medical Applications in the USA and the EU," Journal of Medical Device Regulation (August 2013)
Christopher Pruitt Co-Author, Brian Kelly Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - June 2013," Covington E-Alert (7/31/2013)
Michael Labson Co-Author, Scott Danzis Co-Author, Saurabh Anand Co-Author

"Sunshine Act Data Collection to Begin August 1," Covington E-Alert (7/30/2013)
Stefanie Doebler Co-Author, Anna Kraus Co-Author, Scott Danzis Co-Author, Ellen Flannery Co-Author

"FDA Issues Proposed Rules on Foreign Supplier Verification and Accreditation of Third-Party Auditors Under FSMA," Covington E-Alert (7/30/2013)
Miriam Guggenheim Co-Author, Jeannie Perron Co-Author, Christopher Pruitt Co-Author, Melissa Whittingham Co-Author

"HRSA Issues Final 340B Orphan Drug Exclusion Rule Imposing New Obligations on Covered Entities and Creating New Risks for Manufacturers," Covington E-Alert (7/26/2013)
Jennifer Plitsch Co-Author, Christopher Pruitt Co-Author, Stephanie Barclay Co-Author

"China Opens Broad Investigation Into Pharmaceutical Pricing," Covington E-Alert (7/19/2013)
Shaoyu Chen Co-Author, John Graubert Co-Author, Weishi Li Co-Author, James O'Connell Co-Author, Daniel Spiegel Co-Author, Timothy Stratford Co-Author, Yan Luo Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - May 2013," Covington E-Alert (6/27/2013)
Michael Labson Co-Author, Scott Danzis Co-Author

"Court Establishes Deadlines for FDA to Complete Rulemaking Required by the FSMA," Covington E-Alert (6/25/2013)
Miriam Guggenheim Co-Author, Jeannie Perron Co-Author, Melissa Whittingham Co-Author

"Regulation of Drug Promotion in China," Update (Reprinted with Permission of FDLI) (May/June 2013)
Nan Lou Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - April 2013," Covington E-Alert (5/30/2013)
Michael Labson Co-Author, Scott Danzis Co-Author

"Sunshine Obligations for the Healthcare Industry Apply," Covington E-Alert (5/24/2013)
Peter Bogaert Co-Author, Sarah Forest Co-Author

"Institute of Medicine Releases Report on Sodium Intake Assessment," Covington E-Alert (5/17/2013)
Miriam Guggenheim Co-Author, Jeannie Perron Co-Author, Melissa Whittingham Co-Author

"D.C. District Court Rules FDA Has Inherent Authority to Rescind 510(k) Clearance in "Rare Situation"," Covington E-Alert (4/26/2013)
Ellen Flannery Co-Author, Scott Danzis Co-Author, Krista Carver Co-Author, Jennifer Schwartz Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - March 2013," Covington E-Alert (4/15/2013)
Michael Labson Co-Author, Scott Danzis Co-Author, Saurabh Anand Co-Author

"CFDA Issues Proposed Regulations on Medical Devices," Covington E-Alert (4/9/2013)
Shaoyu Chen Co-Author, Nan Lou Co-Author, Ellen Flannery Co-Author, Scott Danzis Co-Author

"United States," The Life Sciences Law Review (April 2013)
Richard Kingham Co-Author, Robin Blaney Co-Author, Peter Bogaert Co-Author, Grant Castle Co-Author, Shaoyu Chen Co-Author, Sarah Cowlishaw Co-Author, Sarah Forest Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - February 2013," Covington E-Alert (3/28/2013)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"China Reorganizes the SFDA and Appoints a New Commissioner," Covington E-Alert (3/25/2013)
Shaoyu Chen Co-Author, Ellen Flannery Co-Author, Mingham Ji Co-Author

"2012 End-of-Year Summary of FDA Promotional Enforcement Activity," Covington E-Alert (3/18/2013)
Michael Labson Co-Author, Scott Cunningham Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Rethinking the FDA’s Regulation of Mobile Medical Apps," The SciTech Lawyer (Winter/Spring 2013)
Scott Danzis Co-Author, Christopher Pruitt Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - January 2013," Covington E-Alert (2/27/2013)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"CMS Issues Final Rule to Implement the Sunshine Act," Covington E-Alert (2/13/2013)
Anna Kraus Co-Author, Stefanie Doebler Co-Author, Meghan Monaghan Co-Author

"Clinical Trial Developments in 2012," Covington E-Alert (2/1/2013)
Scott Cunningham Co-Author, Afia Asamoah Co-Author, Noellyn Davies Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - December 2012," Covington E-Alert (1/28/2013)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"FDA Releases Proposed Rule for Hazard Analysis and Risk-Based Preventive Controls and Current Good Manufacturing Practices for Human Food," Covington E-Alert (1/10/2013)
Gerald Masoudi Co-Author, Miriam Guggenheim Co-Author, Jeannie Perron Co-Author, Christopher Pruitt Co-Author, MaryJoy Ballantyne Co-Author, Matthew Hegreness Co-Author

"FDA Releases Proposed Rule for Produce Safety Under FSMA," Covington E-Alert (1/10/2013)
Gerald Masoudi Co-Author, Miriam Guggenheim Co-Author, Jeannie Perron Co-Author, Christopher Pruitt Co-Author, Mingham Ji Co-Author

"Chinese Regulation of Off-label Use of Drugs," Food and Drug Law Journal (re-printed with permission of The Food and Drug Law Institute) (2013)
Nan Lou Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - November 2012," Covington E-Alert (12/28/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Second Circuit Recognizes Significant First Amendment Protections for Off-Label Promotion," Covington E-Alert (12/7/2012)
Scott Cunningham Co-Author, Ellen Flannery Co-Author, Gerald Masoudi Co-Author, Krista Carver Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (12/3/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"The U.S. Biosimilar Pathway Nearly Three Years Later," GxP Lifeline (December 2012)
Laura Sim Co-Author

"The Statutory Authority of FDA to Regulate Cosmetics: A Response to Thomas Cluderay and Jason Rano’s Should Congress Expand FDA Authority Over Cosmetics and If So, How?," Food & Drug Policy Forum (Volume 2) (11/16/2012)
Peter Hutt Author

"Comparative Claims: Learning from FDA Warning and Untitled Letters," Regulatory Focus (November 2012)
Stefanie Doebler Author

"Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (10/31/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"From Soup to Nuts: Regulatory, Legal and Communications Issues Involved in Food Recalls," Food Safety Magazine (October/November 2012)
Marialuisa Gallozzi Co-Author, Miriam Guggenheim Co-Author, Suzan Charlton Co-Author, Christopher Pruitt Co-Author

"FDA Begins Biennial Registration Renewal," Covington E-Alert (10/22/2012)
Miriam Guggenheim Co-Author, Christopher Pruitt Co-Author, Jeannie Perron Co-Author

"FDA Delays Biennial Registration Renewal," Covington E-Alert (10/4/2012)
Miriam Guggenheim Co-Author, Jeannie Perron Co-Author, Christopher Pruitt Co-Author

"France - Changes to Rules for Advertising Medical Devices and IVDs," Covington E-Alert (10/3/2012)
Peter Bogaert Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - August 2012," Covington E-Alert (9/28/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Biennial Registration for Food Facilities to Begin Soon, Despite Uncertainties About Requirements," Covington E-Alert (9/27/2012)
Miriam Guggenheim Co-Author, Christopher Pruitt Co-Author

"New Medical Devices Regulations in the EU," Covington E-Alert (9/26/2012)
Peter Bogaert Co-Author, Grant Castle Co-Author, Wim van Velzen Co-Author

"EU Financial Penalties for Centrally Approved Medicinal Products in Europe - How to Prepare?," Covington Advisory (9/17/2012)
Peter Bogaert Co-Author

"SFDA Issues Proposed Regulations for the Administration of Inspections of Foreign Drug Manufacturers," Covington E-Alert (September 2012)
Shaoyu Chen Co-Author, Scott Cunningham Co-Author

"What’s in a Name?," European Pharmaceutical Contractor (September 2012)
Peter Bogaert Co-Author, Sarah Cowlishaw Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - July 2012," Covington E-Alert (8/31/2012)
Julia Post Co-Author, Michael Labson Co-Author, Scott Danzis Co-Author

"FDA Issues Draft Guidance on New Mandatory Information for Food Facility Registration," Covington E-Alert (8/16/2012)
Miriam Guggenheim Co-Author, Christopher Pruitt Co-Author

"Food and Drug Administration Safety and Innovation Act of 2012," Covington E-Alert (8/10/2012)
Scott Cunningham Co-Author, Scott Danzis Co-Author, Ellen Flannery Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"FDA Proposes UDI System for Medical Devices," Journal of Medical Device Regulation (August 2012)
Ellen Flannery Co-Author, Christina Kuhn Co-Author

"New Rules for Clinical Trials Proposed in Europe," Covington E-Alert (8/1/2012)
Peter Bogaert Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - June 2012," Covington E-Alert (7/26/2012)
Julia Post Co-Author, Michael Labson Co-Author, Scott Danzis Co-Author

"FDA Issues Proposed Rule to Establish a Unique Device Identification System for Medical Devices," Covington Advisory (7/16/2012)
Ellen Flannery Co-Author, Scott Danzis Co-Author, Christina Kuhn Co-Author

"FDA Confirms Delay in Enforcement of Key FSMA Provisions," Covington E-Alert (6/29/2012)
Miriam Guggenheim Co-Author, Jeannie Perron Co-Author, Christopher Pruitt Co-Author

"Supreme Court Rejects GSK Drug Sales Representatives Challenge to Exempt Status Under FLSA," Covington E-Alert (6/28/2012)

"SFDA Issues Draft Regulations Blacklisting Violators of Certain Drug or Device Laws," Covington E-Alert (6/14/2012)
Shaoyu Chen Co-Author, Eric Carlson Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - May 2012," Covington E-Alert (6/11/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"FCC Takes Steps to Make More Spectrum Available for Wireless Medical Devices," Covington Advisory (6/7/2012)
Scott Danzis Co-Author, Ellen Flannery Co-Author, Christopher Pruitt Co-Author, Matthew DelNero Co-Author, Lindsey Tonsager Co-Author

"Cost Considerations Should Not Drive Off-label Drug Use in the EU," Scrip Regulatory Affairs (June 2012)
Peter Bogaert Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - April 2012," Covington E-Alert (5/29/2012)
Julia Post Co-Author, Michael Labson Co-Author, Scott Danzis Co-Author

"European Commission Adopts List of General Health Claims," Covington E-Alert (5/25/2012)
Peter Bogaert Co-Author, Grant Castle Co-Author, Brian Kelly Co-Author

"World Health Organization to Discuss Research and Development Treaty," Covington E-Alert (5/8/2012)
Daniel Spiegel Co-Author, Kristen Eichensehr Co-Author

"CMS Delays Physician Payments Sunshine Act Data Collection Requirement," Covington E-Alert (5/7/2012)
Stefanie Doebler Co-Author, Anna Kraus Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - March 2012," Covington E-Alert (4/30/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"FDA Issues Draft Guidance on the Use of Nanotechnology in Manufacturing of Food Substances and Cosmetic Products," Covington E-Alert (4/24/2012)
Scott Cunningham Co-Author, Scott Danzis Co-Author, Clausen Ely Co-Author, Miriam Guggenheim Co-Author, Jeannie Perron Co-Author, Theodore Voorhees Co-Author

"Supreme Court Delivers Important Decision on Patent Eligibility," Covington E-Alert (3/23/2012)
Natalie Derzko Co-Author, Ellen Flannery Co-Author, Christopher Sipes Co-Author, Andrea Reister Co-Author, Jeffrey Elikan Co-Author, Paul Berman Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - February 2012," Covington E-Alert (3/22/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Revision of the Rules on Pricing and Reimbursement of Medicines (the "Transparency Directive") in the European Union," Covington E-Alert (3/1/2012)
Peter Bogaert Co-Author, Grant Castle Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - January 2012," Covington E-Alert (2/29/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"France - A Revolution for the Medical Devices Industry," Covington E-Alert (2/13/2012)

"2011 End-of-Year Summary of FDA Promotional Enforcement Activity," Covington E-Alert (2/7/2012)
Michael Labson Co-Author, Scott Cunningham Co-Author

"FDA Issues Draft Guidance on Evaluating Substantial Equivalence in 510(k) Premarket Notifications," Covington E-Alert (2/7/2012)
Ellen Flannery Co-Author, Krista Carver Co-Author, Christina Kuhn Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - December 2011," Covington E-Alert (1/19/2012)
Michael Labson Co-Author, Scott Cunningham Co-Author, Scott Danzis Co-Author

"FDA Releases Draft Guidance on Responding to Unsolicited Requests for Off-Label Information and Seeks Stakeholder Input on Scientific Exchange," Covington E-Alert (1/9/2012)
Michael Labson Co-Author, Scott Cunningham Co-Author, Scott Danzis Co-Author, Afia Asamoah Co-Author

"CMS Issues Proposed Rule Implementing Sunshine Act Reports Regarding Ownership or Investment Interests Held by Physicians," Covington E-Alert (1/3/2012)
Anna Kraus Co-Author, Stefanie Doebler Co-Author

"Belgium," Life Sciences Handbook (2012)
Peter Bogaert Co-Author

"Key Considerations for European M&A in the Life Sciences Sector," PLC Life Sciences Handbook 2012 (2012)
Daniel Pavin Co-Author, James Halstead Co-Author, Robin Blaney Co-Author, Chris Bracebridge Co-Author, Miranda Cole Co-Author, Guy Dingley Co-Author, Morag Peberdy Co-Author, John Rupp Co-Author

"CMS Issues Proposed Rule Implementing Sunshine Act: Review, Correction, and Publication of Data on Public Website," Covington E-Alert (12/30/2011)
Anna Kraus Co-Author, Stefanie Doebler Co-Author

"CMS Issues Proposed Rule Implementing Sunshine Act," Covington E-Alert (12/23/2011)
Stefanie Doebler Co-Author, Anna Kraus Co-Author

"United States Drug and Device Law - Regulation and Enforcement," Educational Program for Chinese SFDA Officials, New Haven, CT (11/9/2011)
Ellen Flannery

"Minimizing Financial and Recall Risk After the Food Safety Modernization Act," Food Safety Magazine (November 2011)
Marialuisa Gallozzi Co-Author, Miriam Guggenheim Co-Author

"FDA Issues Draft Guidance on Mobile Medical Applications," Journal of Medical Device Regulation (November 2011)
Scott Danzis Co-Author, Ellen Flannery Co-Author, Christopher Pruitt Co-Author

"IOM Releases Report on Front-of-Package Nutrition Labeling," Covington E-Alert (10/24/2011)
Miriam Guggenheim Co-Author, Jeannie Perron Co-Author

"Brainstorm: Food Safety Modernization Act," Food Manufacturing (October 2011)
Marialuisa Gallozzi Co-Author, Miriam Guggenheim Co-Author

"IRS Issues Regulations on Calculation of Branded Prescription Drug Fee," Covington E-Alert (9/1/2011)
Anna Kraus Co-Author, Katherine Phillips Co-Author

"FDA Issues Draft Guidance on Mobile Medical Applications," Covington E-Alert (8/4/2011)
Scott Danzis Co-Author, Ellen Flannery Co-Author, Christopher Pruitt Co-Author

"FDA Issues New Dietary Ingredient Notification Draft Guidance," Covington E-Alert (7/6/2011)
Miriam Guggenheim Co-Author, Clausen Ely Co-Author, Jeannie Perron Co-Author, Christopher Pruitt Co-Author

"FDA Issues Final Rule Regarding Labeling of Sunscreen Products," Covington E-Alert (6/22/2011)
Jeannie Perron Co-Author, Christina Kuhn Co-Author

"FDA Issues Draft Guidance on the Application of Nanotechnology," Covington E-Alert (6/22/2011)
Clausen Ely Co-Author, Scott Cunningham Co-Author, Theodore Voorhees Co-Author

"FDA Issues Draft Guidance Regarding Research Use Only and Investigational Use Only In Vitro Diagnostic Products," Covington E-Alert (6/13/2011)
Ellen Flannery Co-Author, Scott Danzis Co-Author, Christopher Pruitt Co-Author

"Interagency Working Group Holds Public Forum on Food Marketed to Children," Covington E-Alert (5/25/2011)
Miriam Guggenheim Co-Author, Melissa Whittingham Co-Author

"Interagency Working Group Releases Preliminary Proposed Nutrition Principles for Food Marketed to Children," Covington E-Alert (4/29/2011)

"Accountable Care Organization Basics," Covington E-Alert (4/15/2011)
Kevin Shortill Co-Author, Katherine Phillips Co-Author

"FDA Issues Proposed Rules on Nutrition Labeling For Menus in Certain Restaurants and Vending Machines," Covington E-Alert (4/6/2011)
Miriam Guggenheim Co-Author, Melissa Whittingham Co-Author

"FDA Considers Link Between Consumption of Synthetic Color Additives in Food and Adverse Effects on Children's Behavior," Covington E-Alert (4/4/2011)
Miriam Guggenheim Co-Author, Melissa Whittingham Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - February 2011," Covington E-Alert (3/9/2011)
Stefanie Doebler Co-Author

"USDA and HHS Announce 2010 Dietary Guidelines for Americans," Covington E-Alert (2/2/2011)
Miriam Guggenheim Co-Author

"Food Industry Groups Announce "Nutrition Keys" Front-of-Package Labeling System," Covington E-Alert (1/25/2011)
Miriam Guggenheim Co-Author

"FDA Reopens the Comment Period for the Generally Recognized as Safe ("GRAS") Notification Proposed Rule," Covington E-Alert (1/3/2011)
Clausen Ely Co-Author, Miriam Guggenheim Co-Author, Jeannie Perron Co-Author

"Biosimilar Regulation: Important Considerations and Global Developments," Life Sciences Handbook 2011 (2011)
Peter Bogaert Co-Author, Laura Sim Co-Author

"Belgium," Life Sciences Handbook (2011)
Peter Bogaert Co-Author

"Recent Changes in the Anti-corruption Landscape for Healthcare Companies," Life Sciences Handbook 2011 (2011)
John Rupp Co-Author

"Congress Passes the FDA Food Safety Modernization Act," Covington E-Alert (12/22/2010)
Miriam Guggenheim Co-Author, Clausen Ely Co-Author, Jeannie Perron Co-Author, Christopher Pruitt Co-Author

"Consumer Product Safety Commission Publishes Consumer Product Safety Database Rule," Covington E-Alert (12/14/2010)
Sarah Wilson Co-Author, Matthew Krauss Co-Author

"Health Care Reform: Federal Court Strikes Down Individual Coverage Mandate; Rest of Law Unaffected," Covington E-Alert (12/13/2010)
Rachel Grunberger Co-Author

"FDA Issues Proposed Rule on Phytosterol Health Claims," Covington E-Alert (12/9/2010)
Jeannie Perron Co-Author, Miriam Guggenheim Co-Author

"An Unofficial Legislative History of the Biologics Price Competition and Innovation Act of 2009," Food and Drug Law Journal (With permission from FDLI) (12/6/2010)
Krista Carver Co-Author, Jeffrey Elikan Co-Author, Erika Lietzan Co-Author

"IRS Issues Guidance on Calculation of Branded Prescription Drug Fee," Covington E-Alert (December 2010)

"NICE Powers May Be Clipped in the UK Pharmaceutical Pricing Overhaul," Covington E-Alert (11/10/2010)
Grant Castle Co-Author, Brian Kelly Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - August 2010," Covington E-Alert (11/4/2010)

"Summary of FDA Advertising and Promotion Enforcement Activities - September 2010," Covington E-Alert (11/4/2010)

"CDRH: 510(k)s and Science in Regulatory Decision-Making," Journal of Medical Device Regulation (November 2010)
Ellen Flannery Co-Author, Scott Danzis Co-Author, Christopher Pruitt Co-Author

"IOM Holds First Phase II Committee Meeting on Front-of-Package Nutrition Rating Systems and Symbols," Covington E-Alert (10/29/2010)

"Institute of Medicine Holds Workshop on Legal Strategies in Childhood Obesity Prevention," Covington E-Alert (10/25/2010)
Miriam Guggenheim Co-Author, Christopher Pruitt Co-Author

"IOM Releases Phase I Report on Front-of-Package Nutrition Labeling," Covington E-Alert (10/14/2010)
Miriam Guggenheim Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - July 2010," Covington E-Alert (9/23/2010)

"FDA Considers Application for Genetically Engineered Salmon," (9/22/2010)
Jeannie Perron Co-Author, Miriam Guggenheim Co-Author, Melissa Whittingham Co-Author

"Mid-Year Update: DDMAC Enforcement Activity," Covington E-Alert (9/7/2010)

"FDA Issues Draft Guidance Regarding Implementation of the New Federal Menu Labeling Requirements," Covington E-Alert (8/25/2010)
Miriam Guggenheim Co-Author

"Senate Leaders Release Amended Version of Food Safety Bill," Covington E-Alert (8/18/2010)
Miriam Guggenheim Co-Author, Christopher Pruitt Co-Author

"FDA's 510(K) Working Group Releases Preliminary Report and Recommendations," Covington E-Alert (8/10/2010)
Ellen Flannery Co-Author, Scott Danzis Co-Author, Christopher Pruitt Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (8/9/2010)

"CMS Releases Final Discount Program Model Agreements," Covington E-Alert (8/3/2010)
Anna Kraus Co-Author, Rachel Grunberger Co-Author

"FDA Plans to Regulate Laboratory Developed Tests as Devices," Journal of Medical Device Regulation (August 2010)
Ellen Flannery Co-Author, Scott Danzis Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities," (7/6/2010)

"FDA Announces Public Meeting to Discuss Plans to Regulate Laboratory Developed Tests as Medical Devices," Covington E-Alert (6/21/2010)
Ellen Flannery Co-Author, Scott Danzis Co-Author

"2010 Dietary Guidelines Advisory Committee Report," Covington E-Alert (6/16/2010)
Miriam Guggenheim Co-Author

"Institute of Medicine Releases Report on FDA’s Role in Enhancing Food Safety," Covington E-Alert (6/10/2010)

"Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (6/3/2010)
Ellen Flannery Co-Author, Peter Safir Co-Author, Michael Labson Co-Author, Scott Cunningham Co-Author, Scott Danzis Co-Author, Stefanie Doebler Co-Author

"FDA Releases Updated Guidance on the Reportable Food Registry," Covington E-Alert (5/25/2010)
Jeannie Perron Co-Author, Melissa Whittingham Co-Author

"President’s Task Force on Childhood Obesity Releases Report; Includes Recommendations for Marketing Foods to Children," Covington E-Alert (5/13/2010)
Miriam Guggenheim Co-Author, Daniel Spiegel Co-Author

"FDA Requests Comments and Information on Front-of-Package Labeling Systems," Covington E-Alert (4/29/2010)
Clausen Ely Co-Author, Gerald Masoudi Co-Author, Miriam Guggenheim Co-Author

"Health Care Reform: Annual Fee On Prescription Drug Manufacturers And Excise Tax On Medical Device Manufacturers," Covington E-Alert (4/29/2010)
Anna Kraus Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (4/28/2010)
Ellen Flannery Co-Author, Peter Safir Co-Author, Michael Labson Co-Author, Scott Cunningham Co-Author, Scott Danzis Co-Author, Stefanie Doebler Co-Author

"Institute of Medicine Releases Report on Strategies to Reduce Sodium Intake in the United States; FDA Considering Recommendations," Covington E-Alert (4/22/2010)
Miriam Guggenheim Co-Author

"Health Care Reform: Biosimilars Licensing and Reimbursement," Covington E-Alert (4/12/2010)
Jeffrey Elikan Co-Author, Melissa Whittingham Co-Author

"IOM Committee Holds Public Workshop Regarding Front-Of-Package Labeling Systems," Covington E-Alert (4/12/2010)
Miriam Guggenheim Co-Author, Jennifer Schwartz Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (4/5/2010)

"Health Care Reform: Medicaid Prescription Drug Reimbursement," Covington E-Alert (April 2010)
Stefanie Doebler Co-Author, Anna Kraus Co-Author

"Health Care Reform: Therapeutic Discovery Project Tax Credits and Grants for Small Employers," Covington E-Alert (April 2010)
Anna Kraus Co-Author, Noellyn Davies Co-Author

"Health Care Reform: 340B Drug Pricing Program," Covington E-Alert (April 2010)
Anna Kraus Co-Author, Jennifer Plitsch Co-Author

"Health Care Reform: Sunshine Provisions," Covington E-Alert (April 2010)
Anna Kraus Co-Author

"Health Care Reform: Medicare Part D Donut Hole and Protected Classes," Covington E-Alert (April 2010)
Anna Kraus Co-Author, Rachel Grunberger Co-Author

"Nutrition Labeling for Chain Restaurant Foods Established by Healthcare Reform Legislation," Covington E-Alert (3/23/2010)
Miriam Guggenheim Co-Author, MaryJoy Ballantyne Co-Author

"Colliding, Again, with the First Amendment," The National Law Journal (3/15/2010)
Gerald Masoudi Co-Author, Melissa Whittingham Co-Author

"Food Safety: GAO Report Concludes that FDA Should Strengthen Its Oversight of Food Ingredients Determined to be Generally Recognized as Safe (GRAS)," Covington E-Alert (3/10/2010)
Miriam Guggenheim Co-Author, MaryJoy Ballantyne Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (3/5/2010)

"FDA Issues 17 Warning Letters as Part of an Enforcement Sweep Regarding Food Labeling," Covington E-Alert (3/4/2010)

"2009 End-Of-Year Summary of DDMAC and APLB Enforcement Activity," Covington E-Alert (1/28/2010)
Peter Safir Co-Author, Scott Cunningham Co-Author, Michael Labson Co-Author, Scott Danzis Co-Author, Stefanie Doebler Co-Author

"National Salt Reduction Initiative Announces Voluntary Salt Reduction Targets for Food Manufacturers and Restaurants," Covington E-Alert (1/12/2010)

"European Union Regulation of In Vitro Diagnostic Medical Devices," In Vitro Diagnostics: The Complete Regulatory Guide (Chapter (8) with permission from FDLI ) (2010)
Grant Castle Co-Author, Robin Blaney Co-Author

"Belgium," Life Sciences Handbook (2009/10)
Peter Bogaert Co-Author,
Gabriela Klasa, Co-Author

"Companion Diagnostics: Evolving FDA Regulation and Issues for Resolution," In Vitro Diagnostics: The Complete Regulatory Guide (Chapter (8) with permission from FDLI ) (2010)
Krista Carver Author

"Tackling Pharmaceutical Crime: Initiatives at Multinational, EU and National Level," PLC Life Sciences Handbook 2009/10 (2009/10)
Lisa Peets Co-Author

"Employee’s Rights to Compensation for Inventions - A European Perspective," PLC Life Sciences Handbook 2009/10 (2009/10)
Morag Peberdy Co-Author, Alain Strowel Co-Author

"FTC Hosts Forum on Food Marketing to Children: Draft Nutritional Standards for Food Marketing to Kids (Ages 2-17) Released," Covington E-Alert (12/16/2009)
John Graubert Co-Author

"Summary Of DDMAC And APLB Enforcement Correspondence - October 2009," Covington E-Alert (11/30/2009)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Food Safety Bill Clears Senate Committee," Covington E-Alert (11/20/2009)

"Maine Adopts Final Clinical Trial Reporting Regulations," Covington E-Alert (11/9/2009)

"Summary of DDMAC and APLB Enforcement Correspondence - September 2009," Covington E-Alert (10/30/2009)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Reminder -- Deadline For Reporting Cosmetic Products Under the California Safe Cosmetics Program," Covington E-Alert (9/15/2009)
Jeannie Perron Co-Author, MaryJoy Ballantyne Co-Author

"FDA Launches Reportable Food Registry," Covington E-Alert (9/15/2009)
Clausen Ely Co-Author, Michael Labson Co-Author, Gerald Masoudi, Jeannie Perron Co-Author

"No More Red Tape: MHRA Awaits Tougher Sanctioning Powers in the UK," RAJ Devices (September/October 2009)
Grant Castle Co-Author, Brian Kelly Co-Author

"Summary of DDMAC and APLB Enforcement Correspondence - July 2009," Covington E-Alert (8/31/2009)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"FDA’s Final Rules Regarding Expanded Access and Charging for Investigational Drugs and CMS Payment Implications," Covington E-Alert (8/26/2009)
Stefanie Doebler Co-Author

"House Passes New Food Safety Bill," Covington E-Alert (7/31/2009)

"Summary of DDMAC and APLB Enforcement Correspondence - June 2009," Covington E-Alert (7/27/2009)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Food Safety Working Group Releases Key Findings," Covington E-Alert (7/9/2009)

"Proposed Changes to Maine’s Clinical Trial Reporting Regulations," Covington E-Alert (6/29/2009)

"Summary of DDMAC and APLB Enforcement Correspondence - May 2009," Covington E-Alert (6/24/2009)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"FDA Releases Draft Guidance for FDAAA Reportable Food Registry," Covington E-Alert (6/19/2009)
Clausen Ely Co-Author, Gerald Masoudi Co-Author, Jeannie Perron Co-Author

"Department of Defense Releases Additional Guidance for Implementation of the New TRICARE Rule," Covington E-Alert (4/14/2009)
Scott Freling Co-Author, Alan Pemberton Co-Author, Jennifer Plitsch Co-Author

"FDA Orders Submission of Data Regarding Certain Class III Pre-Amendment Medical Devices," Covington E-Alert (4/13/2009)
Ellen Flannery Co-Author, Scott Danzis Co-Author

"New Rules for Advanced Medical Technologies," Covington E-Alert (4/2/2009)

"China Enacts New Food Safety Law, Effective June 1, 2009," Covington E-Alert (3/30/2009)
Jeannie Perron Co-Author, Eric Carlson Co-Author

"Trends in DDMAC Enforcement Activity During the Bush Administration," Covington E-Alert (3/30/2009)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"DoD Final Rule Mandates Deeply Discounted Pricing for TRICARE Retail Pharmacy Sales," Covington E-Alert (3/25/2009)
Alan Pemberton Co-Author, Jennifer Plitsch Co-Author, Scott Freling Co-Author

"Federal Spending Bill Creates New Categories of Nominal Price Exclusions," Covington E-Alert (3/20/2009)
Scott Danzis Co-Author, Anna Kraus Co-Author, Stefanie Doebler Co-Author

"How Ill is the European Pharmaceutical Industry?," SCRIP (3/20/2009)
Peter Bogaert Author

"Summary of DDMAC and APLB Enforcement Correspondence - February 2009," Covington E-Alert (3/17/2009)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Putnam & Costa Introduce Comprehensive Food Safety Bill," Covington E-Alert (3/9/2009)
Jeannie Perron Co-Author

"U.S. Supreme Court Rejects Federal Preemption in Wyeth v. Levine," Covington E-Alert (3/9/2009)
Scott Danzis Co-Author, Michael Imbroscio Co-Author, Robert Long Co-Author, Paul Schmidt Co-Author

"Comparative Effectiveness Research Provisions of the American Recovery and Reinvestment Act of 2009," Covington E-Alert (3/6/2009)
Anna Kraus Co-Author

"Bipartisan Food Safety Bill Introduced in the Senate," Covington E-Alert (3/6/2009)
Jeannie Perron Co-Author

"Draft FDA Guidance on Submission and Expedited Review of Abbreviated Laboratory Packages From Accredited Laboratories," Covington E-Alert (2/23/2009)
Jeannie Perron Co-Author

"Summary Of DDMAC And APLB Enforcement Correspondence - January 2009," Covington E-Alert (2/17/2009)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Recalls of FDA-Regulated Products - What You Need to Know," Covington E-Alert (2/9/2009)
Jeannie Perron Co-Author

"USDA Revises Implementation Framework for Import Declarations under Lacey Act Amendments," Covington E-Alert (2/5/2009)
Jeannie Perron Co-Author

"FDA Launches “Secure Supply Chain” Pilot Program To Improve Safety of Imported Drugs and Drug Ingredients," Covington E-Alert (2/4/2009)
Eric Carlson Co-Author

"CPSC Grants One Year Stay Of Some Testing And Certification Requirements," Covington E-Alert (2/3/2009)

"Dingell, Stupak, and Pallone Introduce Food and Drug Safety Import Bill," Covington Advisory (2/2/2009)
Clausen Ely Co-Author, Jeannie Perron Co-Author

"FDA Releases Final Guidance for Evidence-Based Review System for the Scientific Evaluation of Health Claims," Covington E-Alert (1/28/2009)
MaryJoy Ballantyne Co-Author

"FDA Releases Guidance on Voluntary Third-Party Certification Programs for Foods and Feeds," Covington E-Alert (1/26/2009)
Jeannie Perron Co-Author

"FDA Issues Final Guidance on “Good Reprint Practices," Covington E-Alert (1/21/2009)
Scott Danzis Co-Author, Michael Labson Co-Author, Jeannie Perron Co-Author, Peter Safir Co-Author

"Draft Guidance on Good Importer Practices," Covington E-Alert (1/16/2009)
Scott Danzis Co-Author

"Summary Of DDMAC And APLB Enforcement Correspondence - December 2008," Covington E-Alert (1/15/2009)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"FDA Releases Final Guidance for Substantiation of Dietary Supplement Claims," Covington E-Alert (1/9/2009)
Jeannie Perron Co-Author

"FDA Requires Label Declaration of Color Additives -- Cochineal Extract and Carmine," Covington E-Alert (1/7/2009)

"A New History and Discussion of 180-Day Exclusivity," Food and Drug Law Journal (With permission from FDLI) (2009)
Erika Lietzan Co-Author

"FDAAA’s Safety Labeling Provisions," Update (January/February 2009)
Scott Danzis Co-Author

"AdvaMed Adopts Revised Code of Ethics on Interactions with Health Care Professionals," Covington E-Alert (12/23/2008)
Scott Danzis Co-Author, Ellen Flannery Co-Author

"Summary of DDMAC and APLB Enforcement Correspondence - November 2008," Covington E-Alert (12/23/2008)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"FDA Updates Stakeholders on Nutrition-Related Activities," Covington E-Alert (12/16/2008)

"FDA Opens Offices in China: More Inspections Likely," Covington E-Alert (12/15/2008)
Peter Safir Co-Author, Eric Carlson Co-Author

"FDA Delays Enforcement Date for Dietary Supplement Labeling Requirements Under Adverse Event Reporting Law," Covington E-Alert (12/10/2008)
Jeannie Perron Co-Author

"Veterinary Food and Drugs," chapter 7 in FDLI’s 2008 Food and Drug Law and Regulation (2008)
Jeannie Perron Author

"First Circuit Upholds New Hampshire Law Banning Sale of Prescriber Information," Covington E-Alert (12/1/2008)
Stefanie Doebler Co-Author, Anna Kraus Co-Author

"CPSC Issues Rule Relieving Foreign Manufacturers And Private Labelers From Certification Obligation And Allowing Electronic Certifications Under The Consumer Product Safety Improvement Act Of 2008," Covington E-Alert (11/18/2008)
Laura Sim Co-Author

"Summary Of DDMAC And APLB Enforcement Correspondence - October 2008," Covington E-Alert (11/18/2008)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"FDA Issues Broad Import Alert for Milk and Milk-derived Products from China," Covington E-Alert (11/14/2008)
Jeannie Perron Co-Author

"Consumer Product Safety Improvement Act of 2008," Journal of Medical Device Regulation, Vol. 5(4) (11/8/2008)
Laura Sim Co-Author

"FDA Publishes Final Rule on Prior Notice on Imported Food," Covington E-Alert (11/7/2008)
Jeannie Perron Co-Author

"Proposed New Contingency Plan Requirements for Entities Registered or Licensed Under the Animal Welfare Act," Covington E-Alert (10/28/2008)
Jeannie Perron Author

"Product Liability and Reuse of Medical Devices," EURALex (October 2008)
Brian Kelly Co-Author

"FDA Holds Public Hearing on Allergen Advisory Labeling," Covington E-Alert (9/17/2008)
Jeannie Perron Co-Author, Laura Sim Co-Author

"REACH and Its Impact on Medical Devices," Covington E-Alert (September 2008)
Cándido García Molyneux Co-Author

"Summary Of DDMAC and APLB Enforcement Correspondence - July 2008," Covington E-Alert (8/11/2008)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Customs Proposes To Substantially Transform Country-of-Origin Labeling Determinations," Covington E-Alert (8/8/2008)
Clausen Ely Co-Author

"FTC Releases Report on Marketing Food to Children and Adolescents," Covington E-Alert (8/1/2008)
Theodore Voorhees

"Global Harmonization Is Not All That Global: Divergent Approaches in Drug Safety," Food and Drug Law Journal (With permission from FDLI) (August 2008)
Grant Castle Co-Author, Brian Kelly Co-Author

"Fifth Circuit Rules that FDA May Regulate Compounded Drugs as “New Drugs” - Update on Medical Center Pharmacy v. Mukasey," Covington E-Alert (7/29/2008)
Jeannie Perron Co-Author, Scott Danzis Co-Author

"PhRMA Issues Revised Code on Interactions with Healthcare Professionals," Covington E-Alert (7/11/2008)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Summary of DDMAC and APLB Enforcement Correspondence - May 2008," Covington E-Alert (6/9/2008)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"FDA Delays FDAAA Reportable Food Registry Requirements," Covington E-Alert (5/27/2008)
Jeannie Perron Co-Author

"FDA Issues Final BSE Feed Rule," Covington E-Alert (4/25/2008)
Jeannie Perron Co-Author

"The Food and Drug Administration Globalization Act of 2008," Covington E-Alert (4/24/2008)

"European Food Law Update," Covington E-Alert (April 2008)

"European Commission’s Public Consultation on the EU Pharmacovigilance System," EURALex (March 2008)
Grant Castle Co-Author, Robin Blaney Co-Author

"FDA Issues Draft Guidance on the Distribution of Journal Articles and Reference Publications on Unapproved New Uses of Approved or Cleared Medical Products," Covington E-Alert (2/19/2008)
Peter Safir Co-Author, Michael Labson Co-Author

"Summary of DDMAC and APLB Enforcement Correspondence - January 2008," Covington E-Alert (2/12/2008)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"FDA Clarifies Recent Initiatives Affecting OTC Drug Labeling," Covington E-Alert (1/30/2008)

"Recent Trends in DDMAC Enforcement Activity," Covington E-Alert (1/18/2008)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Summary of DDMAC Enforcement Correspondence," Covington E-Alert (1/3/2008)

"FDA Issues Draft Guidance for Dietary Supplement Labeling Urging Use of Full Domestic Address or Telephone Number and Introductory Statement Indicating Use for Reporting Adverse Events," Covington E-Alert (1/2/2008)
Jeannie Perron Co-Author

"Current Regulatory and Legal Considerations for Follow-On Biologics," Clinical Pharmacology and Therapeutics (2008)
Erika Lietzan Co-Author

"A Global View of the First Amendment Constraints on FDA," Food and Drug Law Journal (2008)
Krista Carver Author

"FDA Intends to Reevaluate the Scientific Evidence for Four Currently Permitted Health Claims," Covington E-Alert (12/26/2007)
Clausen Ely Co-Author, Jeannie Perron Co-Author

"FDA Proposes to Prohibit Most Omega-3 Nutrient Content Claims," Covington E-Alert (11/28/2007)
Laura Sim Co-Author, Jeannie Perron Co-Author

"Presidential Working Group and FDA Issue New Plans To Improve Safety of the U.S. Food Supply," Covington E-Alert (11/26/2007)
Clausen Ely Co-Author, Jeannie Perron Co-Author, Noellyn Davies Co-Author

"Summary of DDMAC Enforcement Correspondence - October 2007," Covington E-Alert (11/6/2007)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Recalls of FDA-Regulated Products - What You Need to Know," Covington E-Alert (11/6/2007)
Jeannie Perron Co-Author

"Food and Drug Administration Amendments Act of 2007," Covington E-Alert (10/2/2007)
Michael Labson Co-Author, Peter Safir Co-Author

"Congress Passes New Food Safety Legislation," Covington E-Alert (9/21/2007)
Clausen Ely Co-Author

"New Legislation Regulating Pet Food and Other Animal Feed," Covington E-Alert (9/21/2007)
Jeannie Perron Co-Author

"FDA Releases Proposed Rule Amending The Final Monograph for Over-The-Counter Sunscreen Drug Products," Covington E-Alert (9/4/2007)
Jeannie Perron Co-Author

"First Circuit Resolves Challenge to USDA Regulation of Organic Processed Food Products; Court Recognizes Importance of Interplay of Three Branches of Government," Covington E-Alert (9/3/2007)
Clausen Ely Co-Author

"Summary of DDMAC Enforcement Correspondence - July 2007," Covington E-Alert (8/6/2007)
Michael Labson Co-Author, Peter Safir Co-Author, Stefanie Doebler Co-Author

"Cadbury and the Chocolate Factory," Covington E-Alert (7/19/2007)
Peter Bogaert Co-Author

"Learned Intermediary Doctrine: Required By Fed Law?," Health Law 360 (7/17/2007)
Michael Imbroscio Co-Author, Paul Schmidt Co-Author, Michael Labson Co-Author

"FDA Releases Dietary Supplement CGMP Final Rule," Covington E-Alert (6/29/2007)
Jeannie Perron Co-Author

"Summary of DDMAC Enforcement Correspondence - May 2007," Covington E-Alert (6/8/2007)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"FDA Releases Guidance for Industry on Medical Foods," Covington E-Alert (5/31/2007)
Jeannie Perron Co-Author

"New Hampshire Prescription Data Ban Ruled Unconstitutional," Covington E-Alert (5/17/2007)
Robert Long Co-Author, Anna Kraus Co-Author, Ellen Flannery Co-Author, Peter Safir Co-Author, Stefanie Doebler Co-Author

"CMS Issues Proposal to Revise Clinical Trial Policy National Coverage Determination," Covington E-Alert (5/3/2007)
Anna Kraus Co-Author, Michael Labson Co-Author, Ellen Flannery Co-Author, Peter Safir Co-Author, Stefanie Doebler Co-Author

"The FTC Renews Request for Comments and Proposes Compulsory Orders Targeting Food Marketing to Children and Adolescents," Covington E-Alert (5/2/2007)
Theodore Voorhees Co-Author

"FDA Releases Proposed Rule Revising Regulations Governing Labeling of Foods That Have Been Treated By Irradiation," Covington E-Alert (4/17/2007)
Jeannie Perron Co-Author

"Summary of DDMAC Enforcement Correspondence - March 2007," Covington E-Alert (4/4/2007)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Summary of DDMAC Enforcement Correspondence - January 2007," Covington E-Alert (2/6/2007)
Michael Labson Co-Author, Peter Safir Co-Author, Stefanie Doebler Co-Author

"FDA Releases Proposed Rule Defining Standard for "Gluten-Free" Labeling Claims," Covington E-Alert (1/29/2007)
Laura Sim Co-Author, Clausen Ely Co-Author

"Proposed Rules Regarding Requirements for Expanded Access to Investigational Drugs and Charging for Investigational Drugs," Covington E-Alert (1/26/2007)
Peter Safir Co-Author, Michael Labson Co-Author

"FDA Publishes Proposed Rule on Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants," Covington E-Alert (1/19/2007)
Jeannie Perron Co-Author

"CMS Issues Proposed Rule to Implement Medicaid Drug Pricing and Reimbursement Provisions of the Deficit Reduction Act," Covington E-Alert (1/12/2007)
Anna Kraus Co-Author, Stefanie Doebler Co-Author

"REACH and Its Impact on Medical Devices," Covington E-Alert (January 2007)
Peter Bogaert Co-Author, Grant Castle Co-Author, Cándido García Molyneux Co-Author

"REACH and Its Impact on Pharmaceuticals," Covington E-Alert (January 2007)
Peter Bogaert Co-Author, Grant Castle Co-Author, Cándido García Molyneux Co-Author

"The Food and Drug Administration Amendments Act of 2007," Bio-Science Law Review (2006/2007)
Michael Labson Co-Author

"REACH and Its Impact on Cosmetics," Covington E-Alert (January 2007)
Peter Bogaert Co-Author, Cándido García Molyneux Co-Author, Henriette Tielemans Co-Author

"Food and Drug Law: Cases and Materials," Foundation Press (2007)
Peter Hutt Co-Author, Lewis Grossman Co-Author

"Issues in the Interpretation of 180-Day Exclusivity," 62 Food & Drug L J 49 (2007)
Erika Lietzan Co-Author

"The Dietary Supplement & Nonprescription Drug Consumer Protection Act," Covington E-Alert (12/18/2006)
Jeannie Perron Co-Author

"FSIS Holds Public Meeting on the Definition of the Term "Natural"," Covington E-Alert (12/14/2006)
Clausen Ely Co-Author

"The EC Paediatrics Regime - Implications for the Industry," Covington E-Alert (12/14/2006)
Peter Bogaert Co-Author, Grant Castle Co-Author

"FDA Holds Public Hearing on the Regulation of "Functional Foods" Key Issues Under Consideration Also Relate to Claims Substantiated Generally," Covington E-Alert (12/7/2006)

"Summary of DDMAC Enforcement Correspondence," Covington E-Alert (12/7/2006)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"FDA Announces Public Hearing on Conventional Foods Being Marketed as 'Functional Foods'," Covington E-alert (11/10/2006)
Clausen Ely Co-Author, Jeannie Perron Co-Author

"Summary of DDMAC Enforcement Correspondence," Covington E-Alert (11/6/2006)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Patient Power Within the EMEA," Pharmaceutical Law Insight (November 2006)
Grant Castle Co-Author, Brian Kelly Co-Author

"Proposed Rule Regarding Index of Legally Marketed Unapproved New Animal Drugs for Minor Species," Covington E-Alert (10/13/2006)
Jeannie Perron Co-Author

"California Will Negotiate Drug Prices with Manufacturers in New Discount Drug Program," Covington E-Alert (10/9/2006)
Anna Kraus Co-Author, James Snipes Co-Author, Ethan Posner Co-Author, Michael Labson Co-Author

"Summary of DDMAC Enforcement Correspondence," Covington E-Alert (10/9/2006)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Western District of Texas Compounding Decision on Medical Center Pharmacy v. Gonzales," Covington E-Alert (9/27/2006)
Jeannie Perron Co-Author, Michael Labson Co-Author

"Proposed Rule Regarding Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs," Covington E-Alert (9/14/2006)
Michael Labson Co-Author, Peter Safir Co-Author

"Publication Policy Compliance: Adhering to Legal, Regulatory, and Industry Guidelines," Pharmaceutical Educational Associates, Webinar (9/11/2006)
Scott Cunningham

"Obesity, Food Marketing, and Consumer Litigation: Threat or Opportunity?," Food and Drug Law Journal (September 2006)
Theodore Voorhees Co-Author

"FDA Proposes Ban of OTC Skin Bleaching Products," Covington E-Alert (8/21/2006)
Jeannie Perron Co-Author

"FDA Submits Report to Congress Under FALCPA," Covington E-Alert (8/31/2006)
Jeannie Perron Co-Author, Laura Sim Co-Author

"Recent Trends in DDMAC Enforcement Activity," Covington E-Alert (8/28/2006)
Michael Labson Co-Author, Peter Safir Co-Author, Stefanie Doebler Co-Author

"FDA Allows Third Nutrient Content Claim Notification for Specific Omega-3 Fatty Acids Under FDAMA Authoritative Statement Procedure," Covington E-Alert (7/7/2006)
Jeannie Perron Co-Author

"Scientific and Educational Activities and Introduction to FDA & Overview of New Drug Approval Process," Health Care Compliance Certification Program, Seton Hall University Law School (June 2006)
Erika Lietzan

"FDA Approval of Sandoz's 505(b)(2) Application for a Follow-On Recombinant Human Growth Hormone Product," Covington E-Alert (6/5/2006)
Peter Safir Co-Author, Michael Labson Co-Author, Scott Cunningham Co-Author

"Changes in Food Label Regulations," Global Knowledge Congress Teleconference (5/23/2006)
Miriam Guggenheim

"Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach: A Divided D.C. Circuit Finds New Due Process Right for the Terminally Ill," Covington E-Alert (5/9/2006)
Peter Safir Co-Author, Michael Labson Co-Author

"FTC Requests Public Comment on Food Industry Marketing Practices to Children and Adolescents," Covington E-Alert (3/7/2006)
Clausen Ely Co-Author

"The Impact of the Deficit Reduction Act of 2005 on Pharmaceutical Manufacturers," Covington E-Alert (3/3/2006)
Anna Kraus Co-Author, Ellen Flannery Co-Author, Michael Labson Co-Author, Ethan Posner Co-Author

"FDA Proposes to Require Label Declaration of Carmine and Cochineal Extract," Covington E-Alert (2/10/2006)
Clausen Ely Co-Author

"FDA Final Rule on Prescription Drug Labeling & Statement on Preemption of State Product Liability Laws," Covington E-Alert (1/27/2006)
Peter Safir Co-Author, Michael Labson Co-Author, Scott Danzis Co-Author

"FDA Releases a Revised Guidance for Industry and an Advice to Consumers Document Regarding Food Allergens," Covington E-Alert (12/19/2005)
Clausen Ely Co-Author

"FDA Disclosure in an SEC World," Drug Information Association Annual Conference, Washington, DC (6/29/2005)
Scott Cunningham

"The New Drug Approval Process: NDA Submission and Review," Food and Drug Law Institute, Introduction to Drug Law and Regulation, Washington, DC (February 2005)
Michael Labson

"CMS Establishes PDP and MA Regions," Covington E-Alert (December 2004)
Anna Kraus Co-Author, Michael Labson Co-Author

"2004 Update - 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act," Food and Drug Law Journal (12/1/2004)
Erika Lietzan Author

"CMS Issues Guidelines for the Review of Part D Formularies and Procedures; Additional Bidding Information Also Provided," Covington E-Alert (December 2004)
Anna Kraus Co-Author

"CMS Issues Ten-Year Record Retention Rule for Medicaid Drug Rebate Program," Covington E-Alert (December 2004)
Anna Kraus Co-Author, Scott Danzis Co-Author

"Comments Submitted in Response to CMS Medicare Drug Benefit Proposed Rule," Covington E-Alert (December 2004)
Anna Kraus Co-Author

"FDA Releases Draft Guidance for Substantiation of Dietary Supplement Claims as Part of Agency’s New Dietary Supplement Initiatives," E-Alert (11/30/2004)

"Parallel Trade in Pharmaceutical Products in Europe: The Advocate General’s Opinion in SYFAIT v. GlaxoSmithKline," Competition Law Insight (11/09/2004)
David Hull

"Sponsoring a Medicare Part D Prescription Drug Plan," Covington E-Alert (October 2004)
Anna Kraus Co-Author

"Herbal Remedies," Life Sciences Law & Business (October/November 2004)

"Manufacturer Submission of Average Sales Price Data for Medicare Part B Drugs and Biologicals: CMS Final Rule on ASP Calculation Methodology," Covington E-Alert (9/17/2004)
Anna Kraus Co-Author, Ellen Flannery Co-Author, Michael Labson Co-Author, Ethan Posner Co-Author

"Medicare Part D: USP Draft Model Guidelines and Public Comment Session," Covington E-Alert (August 2004)
Ellen Flannery Co-Author, Michael Labson Co-Author, Peter Safir Co-Author

"Key Provisions of the CMS Medicare Drug Benefit Proposed Rule," Covington E-Alert (August 2004)
Anna Kraus Co-Author, Ellen Flannery Co-Author, Peter Safir Co-Author, Ethan Posner Co-Author

"A Brief History of 180-Day Exclusivity Under the Hatch-Waxman Amendments," 59 Food and Drug Law Journal 287 (June 2004)
Erika Lietzan

"Legal Issues in Long Term Follow-Up of Gene Therapy Trials," American Society of Gene Therapy Workshop on Long Term Follow-up of Gene Therapy Clinical Trials (June 2004)
Lewis Grossman

"The New Drug Approval Requirement," Food & Drug Institute, Introduction to Law and Regulation (4/29/2004)
Scott Danzis

"Manufacturer Submission of Average Sales Price Data for Medicare Part B Drugs and Biologicals: CMS Interim Final Rule," Covington E-Alert (4/14/2004)
Anna Kraus Co-Author, Ellen Flannery Co-Author, Peter Safir Co-Author, Ethan Posner Co-Author

"Average Wholesale Price Reform Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003," Covington E-Alert (12/11/2003)
Anna Kraus Co-Author, Ellen Flannery Co-Author, Peter Safir Co-Author, Michael Labson Co-Author

"Drug Import Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003," Covington Report (12/8/2003)
Peter Safir Co-Author, Michael Labson Co-Author

"Hatch-Waxman Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003," Covington Report (12/8/2003)
Peter Safir, Paul Berman, Michael Labson, Scott Danzis

"Prescription Drug Benefit Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003," Covington E-Alert (11/26/2003)
Anna Kraus Co-Author, Michael Labson Co-Author, Ellen Flannery Co-Author, Peter Safir Co-Author

"The PhRMA Code: A New Roadmap for Industry-Physician Interactions," American Medical Ass’n Virtual Mentor (July 2003)
Michael Labson

"The PhRMA Code: A New Roadmap for Industry-Physician Interactions," Virtual Mentor (7/1/2003)
Michael Labson Author

"Pediatric Priorities: Legislative and Regulatory Initiatives to Expand Research on the Use of Medicines in Pediatric Patients," Journal of Health Care Law & Policy, Vol. 6 No. 1 (11/1/2002)
Michael Labson Author

"Interim Final Rule Concerning Records and Reports Concerning Experience with Approved New Animal Drugs," (3/11/2002)Covington & Burling

"Informed Consent in the Military: Fighting a Losing Battle Against the Anthrax Vaccine," 28 Am. J.L. & Med. 325 (2002)

"The Feds Increasing Focus on the Pharmaceutical Industry," Update Magazine 2001, Issue 6 with permission from FDLI (11/30/2001)
Ethan Posner Co-Author

"On the Agenda?: Food Safety and the World Trade Organization," Washington Legal Foundation (10/31/2001)
Stuart Eizenstat Author

"Interim Rule Concerning Importation Prohibitions Because of Bovine Spongiform Encephalopathy," (8/27/2001)Covington & Burling

"The State of CVM," FDLI Update (6/1/2001)
Jeannie Perron Co-Author

"Memorandum re: Final Rule Concerning "Structure or Function" Claims for Dietary Supplements," Covington Report (1/13/2000)

"The Washington Legal Foundation Decision," (7/30/1999)
Michael Labson Author

"FDA Proposal Concerning "Structure or Function" Claims for Dietary Supplements," Covington Alert (4/29/1998)Covington & Burling

"Food and Drug Administration Modernization Act of 1997 (Annotated Review)," Covington Alert (12/12/1997)Covington & Burling

"Food and Drug Administration Modernization Act of 1997 (Review)," (11/14/1997)Covington & Burling

"FDA Reform Legislation: Its Effect on Animal Drugs," Covington Alert (11/12/1997)Covington & Burling

"Dietary Supplement Health and Education Act of 1994," Covington Report (10/12/1994)

"Liability Exposure for Exclusion and Inclusion of Women as Subjects in Clinical Studies," Women in Health (6/16/1994)
Ellen Flannery Author