Publications

Searched Practice: Food & Drug

"FDA Issues Draft Guidance Regarding Implementation of the New Federal Menu Labeling Requirements," Covington E-Alert (8/25/2010)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

"Senate Leaders Release Amended Version of Food Safety Bill," Covington E-Alert (8/18/2010)
Eugene Lambert Co-Author, 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)
Erika Lietzan Co-Author, Alissa Jijon Co-Author, Elizabeth Jungman Co-Author

"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, Eugene Lambert

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

"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, Elizabeth Jungman Co-Author, Stefanie Doebler Co-Author, Alissa Jijon 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)
Eugene Lambert Co-Author, Miriam Guggenheim Co-Author, Daniel Spiegel 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, Marie Boyd Co-Author

"FDA Requests Comments and Information on Front-of-Package Labeling Systems," Covington E-Alert (4/29/2010)
Eugene Lambert Co-Author, Clausen Ely Co-Author, Gerald Masoudi Co-Author, Miriam Guggenheim 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, Elizabeth Jungman Co-Author, Stefanie Doebler Co-Author, Alissa Jijon 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, Eugene Lambert Co-Author

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

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

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

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

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

"Nutrition Labeling for Chain Restaurant Foods Established by Healthcare Reform Legislation," Covington E-Alert (3/23/2010)
Peter Hutt Co-Author, Eugene Lambert Co-Author, Miriam Guggenheim Co-Author, Carrie Harney 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)
Peter Hutt Co-Author, Eugene Lambert Co-Author, 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, Elizabeth Jungman Co-Author, Stefanie Doebler Co-Author, Alissa Jijon 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," PLC Life Sciences Handbook 2009/10 (2009/10)
Peter Bogaert Co-Author,
Gabriela Klasa, 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

"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

"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)
Miriam Guggenheim Co-Author, 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, Alissa Jijon 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, Miriam Guggenheim Co-Author, Michael Labson Co-Author, Eugene Lambert, 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)
Erika Lietzan Co-Author, Grail Sipes Co-Author, Elizabeth Jungman Co-Author, 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)
Miriam Guggenheim Co-Author, Marie Boyd Co-Author

"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)
Peter Hutt Co-Author, Clausen Ely Co-Author, Eugene Lambert Co-Author, Gerald Masoudi Co-Author, Jeannie Perron Co-Author, Miriam Guggenheim 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)

"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

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

"Regulatory Issues in Pharmacogenomics," Recorded Webinar, BrightTALK™ Personalized Medicine Summit (3/19/2009)
Grail Sipes

"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)
Alissa Jijon Co-Author, Miriam Guggenheim Co-Author, Eugene Lambert Co-Author, 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, Carrie Harney, Robert Long Co-Author, Erika Lietzan Co-Author, Paul Schmidt Co-Author

"Bipartisan Food Safety Bill Introduced in the Senate," Covington E-Alert (3/6/2009)
Miriam Guggenheim Co-Author, Alissa Jijon Co-Author, Eugene Lambert Co-Author, Jeannie Perron 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, Susan Lee Co-Author, Erika Lietzan 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

"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, Jason Ma Co-Author

"CPSC Grants One Year Stay Of Some Testing And Certification Requirements," Covington E-Alert (2/3/2009)
Eugene Lambert Co-Author, Alissa Jijon Co-Author

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

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

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

"Draft Guidance on Good Importer Practices," Covington E-Alert (1/16/2009)
Scott Danzis Co-Author, Jason Ma 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)
Eugene Lambert Co-Author, Jeannie Perron Co-Author, Miriam Guggenheim Co-Author, Carrie Harney Co-Author

"FDA Requires Label Declaration of Color Additives -- Cochineal Extract and Carmine," Covington E-Alert (1/7/2009)
Miriam Guggenheim Co-Author, Alissa Jijon Co-Author

"Government Regulation of Pricing and Reimbursement of Prescription Medicines: Results of a Recent Multi-Country Review," Food and Drug Law Journal (2009)
Joanna Wheeler Co-Author

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

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

"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

"FDA Updates Stakeholders on Nutrition-Related Activities," Covington E-Alert (12/16/2008)
Eugene Lambert Co-Author, Miriam Guggenheim Co-Author

"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)
Eugene Lambert Co-Author, Jeannie Perron Co-Author, Miriam Guggenheim Co-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, Erika Lietzan Co-Author

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

"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)
Eugene Lambert Co-Author, Laura Sim Co-Author, Alissa Jijon 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)
Miriam Guggenheim Co-Author, 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)
Anne Ware Co-Author, Brian Kelly Co-Author

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

"Collecting and Testing Samples for Pharmacogenomic Research: Issues for Manufacturers of Drug and Biological Products," Update (with permission from FDLI) (September/October 2008)
Grail Sipes 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, Eugene Lambert Co-Author

"FTC Releases Report on Marketing Food to Children and Adolescents," Covington E-Alert (8/1/2008)
Stephen Calkins Co-Author, Eugene Lambert Co-Author, Miriam Guggenheim Co-Author, 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)
Eugene Lambert Co-Author, 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, Erika Lietzan 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)
Carrie Harney Co-Author

"Organic Cosmetics: Current Status & Future Trends," Personal Care Products Council Webinar (4/7/2008)
William Friedman

"European Food Law Update," Covington E-Alert (April 2008)
Joanna Wheeler Co-Author

"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, Susan Lee Co-Author, Erika Lietzan 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)
Eugene Lambert Co-Author, Miriam Guggenheim Co-Author

"Recent Trends in DDMAC Enforcement Activity," Covington E-Alert (1/18/2008)
Peter Safir Co-Author, Michael Labson Co-Author, Erika Lietzan 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)
Eugene Lambert Co-Author, Jeannie Perron Co-Author, Miriam Guggenheim Co-Author

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

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

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

"FDA Proposes to Prohibit Most Omega-3 Nutrient Content Claims," Covington E-Alert (11/28/2007)
Eugene Lambert Co-Author, 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)
Eugene Lambert Co-Author, Clausen Ely Co-Author, Jeannie Perron Co-Author, Miriam Guggenheim 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, Erika Lietzan Co-Author, Peter Safir Co-Author

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

"New Legislation Regulating Pet Food and Other Animal Feed," Covington E-Alert (9/21/2007)
Eugene Lambert Co-Author, 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)
Eugene Lambert Co-Author, 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)
Miriam Guggenheim Co-Author, Clausen Ely Co-Author, Eugene Lambert Co-Author, Elizabeth Letchworth Co-Author, William Friedman 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, Anne Ware Co-Author, Joanna Wheeler Co-Author

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

"FDA Releases Dietary Supplement CGMP Final Rule," Covington E-Alert (6/29/2007)
Eugene Lambert Co-Author, Jeannie Perron Co-Author, Miriam Guggenheim Co-Author, William Friedman 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)
Miriam Guggenheim Co-Author, Eugene Lambert Co-Author, 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, Elizabeth Jungman 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)
Eugene Lambert Co-Author, 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, Carrie Harney Co-Author, Eugene Lambert Co-Author, William Friedman 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, Eugene Lambert 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, Grail Sipes 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)
Eugene Lambert Co-Author, 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

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

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

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

"The Dietary Supplement & Nonprescription Drug Consumer Protection Act," Covington E-Alert (12/18/2006)
Eugene Lambert Co-Author, Jeannie Perron Co-Author, Carrie Harney Co-Author, Miriam Guggenheim Co-Author, William Friedman Co-Author

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

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

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

"FDA Submits Report to Congress Under FALCPA," Covington E-Alert (8/31/2006)
Eugene Lambert Co-Author, Jeannie Perron Co-Author, Miriam Guggenheim 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)
Eugene Lambert Co-Author, Jeannie Perron Co-Author, Miriam Guggenheim 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

"Advanced Therapies in the EU," RAJ (April 2006)
Genevieve Michaux 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, Miriam Guggenheim 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, Eugene Lambert Co-Author, Miriam Guggenheim 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

"Regulation of Drug Manufacturing," FDLI's Introduction to Drug Law and Manufacturing (January 2006)
Erika Lietzan

"The Regulation of Foods and Drugs for Animals Other Than Man: Distorted Mirror or Mineshaft Canary," FDLI, FDA, A Century of Consumer Protection (Wayne Pines, ed) (2006)
Eugene Lambert

"How Organic Came Full Circle," Organic Processing Magazine (January-March 2006)
William Friedman 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, Eugene Lambert Co-Author, Miriam Guggenheim 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

"No More Secrets," Life Sciences Law & Business (February/March 2005)
Joanna Wheeler Author

"The Framework for Global Organic Food Trade Circa 2005: Accomplishments and Challenges," Food and Drug Law Journal (2005)
William Friedman 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 Establishes PDP and MA Regions," Covington E-Alert (December 2004)
Anna Kraus Co-Author, Michael Labson Co-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

"Herbal Remedies," Life Sciences Law & Business (October/November 2004)
Joanna Wheeler Co-Author, Genevieve Michaux Co-Author

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

"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

"The New SEC-FDA Alliance," Business Crimes Bulletin (July 2004)
Jacqueline Wolff 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

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

"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

"Pharmaceutical Balance of Powers: Do the Hatch-Waxman Reforms Restore Equilibrium?," 19th Annual Intellectual Property Law Conference, ABA (April 2004)
Erika Lietzan

"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

"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

"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

"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," Virtual Mentor (7/1/2003)
Michael Labson Author

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

"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)
Eugene Lambert Co-Author, 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