Publications

Searched Practice: Life Sciences

"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"FDA Updates Draft Guidance on Medical Foods," Covington E-Alert (8/16/2013)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

"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

"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

"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

"Market Definition in the Pharmaceutical Sector: Incentives in Article 102 Cases," Inside EU LifeSciences (7/19/2013)
Brian Byrne 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

"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

"United Kingdon," The Life Sciences Law Review (April 2013)
Grant Castle Co-Author, Sarah Cowlishaw 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

"The Threat from Within: Theft of Business Critical Information by Company Insiders," (March 2013)
Chris Bracebridge Co-Author, Kurt Calia Co-Author, David Fagan Co-Author, Marialuisa Gallozzi Co-Author, Robert Haney Co-Author, Robert Newman Co-Author, Richard Shea Co-Author, Lindsey Tonsager 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

"What Drug Manufacturers Need to Know About 340B in 2013," Covington E-Alert (2/21/2013)
Jennifer Plitsch Co-Author, Christopher Pruitt Co-Author, Stephanie Barclay Co-Author

"Private Sector's Role In White House Trade Secrets Plan," Law360 (2/21/2013)
David Fagan Co-Author, James Garland Co-Author, Robert Newman Co-Author, Richard Shea Co-Author, Kristen Eichensehr 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 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

"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

"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

"European Parliament Approval of the EU Patent Package," Covington E-Alert (12/11/2012)
Morag Peberdy Co-Author, Peter Bogaert Co-Author

"Judgment of the Court of Justice in AstraZeneca v Commission," Covington E-Alert (12/10/2012)
David Hull Co-Author, Damien Geradin Co-Author, Peter Bogaert Co-Author, Michael Clancy 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

"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

"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

"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

"China's New Blacklist: The Impact for Drug and Device Lawbreakers," Scrip Regulatory Affairs (September 2012)
Shaoyu Chen Co-Author, Scott Cunningham Co-Author, Eric Carlson 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

"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

"AstraZeneca V. EC — The Advocate General’s Opinion," Law360 (5/31/2012)
David Hull Co-Author, Michael Clancy 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

"The Advocate General's Opinion in AstraZeneca v. Commission," Covington E-Alert (5/17/2012)
David Hull Co-Author, Damien Geradin Co-Author, Peter Bogaert Co-Author, Michael Clancy 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

"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

"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

"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 "Sunshine Act" for the Healthcare Industry," Covington E-Alert (1/20/2012)

"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

"Chinese Pharmaceutical Companies Fined for Antitrust Violations," Covington E-Alert (11/18/2011)
Scott Cunningham Co-Author, John Graubert Co-Author, James O'Connell Co-Author, Timothy Stratford 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

"Agency Workers Regulations - Issues for Life Sciences Companies," Covington E-Alert (6/15/2011)
Grant Castle Co-Author, Christopher Walter Co-Author, Chris Bracebridge Co-Author, Robin Blaney Co-Author

"SFDA Seeks Public Comment on Proposed Drug GMP Inspection Regulations," Covington E-Alert (5/11/2011)
Shaoyu Chen Co-Author, Scott Cunningham Co-Author

"Advertising of Medical Products and Summary of Product Characteristics (SmPC) Before the European Court of Justice," Covington E-Alert (5/9/2011)
Peter Bogaert Co-Author, Grant Castle Co-Author

"E-Health: Ethical and Data Privacy Challenges in the EU," Clinica (April 2011)
Brian Kelly 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

"NICE Powers May Be Clipped in UK Pharmaceutical Pricing Overhaul," EuroWatch (11/30/2010)
Grant Castle Co-Author, Brian Kelly Co-Author

"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

"The Need for Informed Consent in Off-Label Use in the EU," Regulatory Affairs Pharma (November 2010)
Cándido García Molyneux Co-Author, Peter Bogaert Co-Author

"Pharma Buy," The Lawyer (10/14/2010)
Daniel Pavin Co-Author, Grant Castle Co-Author

"Nanomedicines: Regulatory Challenges and Risks Ahead," Regulatory Affairs Journal (October 2010)
Brian Kelly 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

"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

"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

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

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

"Parallel Trade in Pharmaceutical Products in Europe: The European Court of Justice’s Ruling in GSK v Commission," Covington E-Alert (10/9/2009)
Peter Bogaert Co-Author, David Hull 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

"Federal Preemption in the Non-Drug Context After Wyeth v. Levine," Drug Litigation Conference: Pharmaceutical Law and Preemption in a Post-Levine World (June 2009)
Michael Imbroscio

"Nanotechnology and the European Product Liability Directive," RAJ Pharma (April 2009)
Brian Kelly Co-Author

"Belgium," Life Sciences Handbook (2008/09)
Peter Bogaert Co-Author

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

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

"Medical Nanotechnology in Europe," RAJ Pharma (July 2008)
Peter Bogaert Co-Author, Brian Kelly Co-Author

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

"The New EC Financial Penalties Regime - A Bridge Too Far?," PLC Cross-border Life Sciences Handbook (2008)
Peter Bogaert Author

"Parallel Trade in Pharmaceuticals and EC Competition Law," PLC Cross-border Life Sciences Handbook (2008)
David Hull Author

"Summary of DDMAC Enforcement Correspondence - August 2007," Covington E-Alert (9/5/2007)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler 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

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

"Extension of CAM Comment Period," Covington E-Alert (5/24/2007)
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

"Structuring Equity Investments as Part of the Collaboration Transaction," Delivered as part of Transactions in the Life Sciences Sector, London, England (2007)
Edward Britton

"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

"Pharmaceutical Product Liability Update: Rowe v. Hoffmann-La Roche Inc.," Covington E-Alert (3/29/2007)
Michael Imbroscio Co-Author, Paul Schmidt 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 Cosmetics," Covington E-Alert (January 2007)
Peter Bogaert Co-Author, Cándido García Molyneux Co-Author, Henriette Tielemans 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

"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

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

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

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

"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

"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

"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

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

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

"New HHS Regulations Protect Arrangements Involving Health Information Technology," Covington E-Alert (8/24/2006)
Anna Kraus Co-Author, Michael Labson Co-Author

"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

"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

"Proposed FTC Study of Authorized Generics," Covington E-Alert (4/14/2006)
Peter Safir 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

"The Proposed New EC Advanced Therapies Regulation," (2006)
Peter Bogaert 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

"The Covington Life Sciences Monitor," (June 2005)
Peter Bogaert Co-Author

"Parallel Trade in Pharmaceutical Products in Europe: The European Court of Justice's Ruling in Syfait v. GSK," Covington E-Alert (June 2005)
David Hull Co-Author, Peter Bogaert Co-Author

"Country Q&A: Belgium," PLC Cross-border Handbooks: Life Sciences (2005/2006)
Peter Bogaert Co-Author

"Acquisitions and Partnering - Know Your Target," Life Sciences Law & Business, Vol. 1, Issue 5 (December 2004/January 2005)
Edward Britton Co-Author, John Hurvitz Co-Author

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

"Country Q&A: Belgium," Global Counsel Life Sciences Handbook (2004/2005)
Peter Bogaert Co-Author

"EU Pharmaceutical Legislation: An Overview of the Main Changes," Global Counsel Life Sciences Handbook (2004/2005)
Peter Bogaert Author

"EU Technology Licensing and the Life Sciences Sector," PLC Cross-Border Handbook on Life Sciences (2004/2005)
David Hull

"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

"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

"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

"The 2004 Future Medicines Legislation - opening the package," Law & Business, Volume 1, Issues 1&2 (April 2004)
Peter Bogaert Co-Author

"Opening the Package: Part 1," Life Sciences Law & Business (April/May 2004)
Peter Bogaert Co-Author

"SEC and FDA Announce New Referral Program," Covington Report (2/23/2004)

"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

"Country Q&A: Belgium," Global Counsel Life Sciences Industry Report (2003)
Peter Bogaert Author

"Generics and EC Competition Law," PLC Cross-Border Handbook on Life Sciences (2003)
David Hull Co-Author

"The Success of the European Orphan Medicines Regime," Global Counsel Life Sciences Industry Report (3/1/2003)
Peter Bogaert Author

"180-Day Exclusivity is Hotly Contested," National Law Journal (4/15/2002)
Scott Cunningham Co-Author

"Developments in the EU Regulatory Environment for Pharmaceuticals," Global Counsel Life Sciences Industry Report (March 2003)
Peter Bogaert Author

"Genetically Modified Foods Raise New Legal Issues," National Law Journal (6/25/2001)
Kurt Calia Co-Author

"Anatomy of a Biotech Merger - How to Build a Better Biotech Business: Don't Treat It Like Just Another Company," Legal Times (10/12/1998)
Edward Britton Co-Author, John Hurvitz Co-Author