By Jennifer D. Newberger – On August 10, 2012, FDA issued a draft guidance, “Refuse to Accept Policy for 510(k)s.” This draft guidance largely mirrors the recently issued draft guidance for premarket approval applications, “Acceptance and Filing Review for Premarket Approval Applications (PMAs),” on which we …
It’s that time of year again when we at FDA Law Blog turn to our loyal readers and ask for your help. The American Bar Association (“ABA”) announced that it is now accepting nominations for the 2012 Blawg 100 (the top 100 legal blogs – …
By Kurt R. Karst – That’s the picture conjured up when we plugged some dates into the new model for calculating forfeiture of 180-day generic drug marketing exclusivity for certain ANDAs – what we are calling “window ANDAs” – covered by Section 1133 of the recently …
By Larry K. Houck – The Drug Enforcement Administration (“DEA”) recently amended its regulations to allow practitioners to issue electronic prescriptions for controlled substances (“EPCS”) in lieu of hardcopy paper prescriptions. See 75 Fed. Reg. 16,236 (March 31, 2010). DEA requires that any electronic prescription …
By Kurt R. Karst – There’s a first time for everything! And on August 8th, 2012, FDA decided, for the first time since the enactment of the Orphan Drug Act, to rescind a period of 7-year orphan drug exclusivity. The decision came in the form of …
By Carmelina G. Allis – On August 2, 2012, the FDA published a final rule amending its regulations in 21 C.F.R. Part 807 to reflect the 2007 statutory amendments to the device registration and listing provisions of the Federal Food, Drug, and Cosmetic Act ("FDC Act"). …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Anne Walsh will moderate a panel on “Trends and Priorities in Enforcement” at this year’s Food and Drug Law Institute’s (“FDLI”) Advertising and Promotion Conference. The conference will be held in Washington, DC on October …
By Kurt R. Karst – We were eager to delve into the Federal Circuit’s recent 2-1 decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. (Docket Nos. 2012-1062, -1103, -1104) concernng the scope of the Hatch-Waxman “safe harbor” provision at 35 U.S.C. § 271(e)(1), particularly in …
By Kurt R. Karst – There’s a lot of parlance (legal and scientific) bandied about in the food and drug world, and perhaps nowhere more so than in the world of Hatch-Waxman. Things can get confusing. Take, for example, the term “Reference Listed Drug,” or “RLD.” FDA’s …
By Riëtte van Laack – The U.S. Government Accountability Office ("GAO") released a report on FDA’s food recall process prepared in response to a congressional directive in the Food Safety Modernization Act ("FSMA"), which provided FDA with mandatory recall authority for foods. In evaluating FDA’s implementation, the …
By Ricardo Carvajal – According to an informal policy, FDA considers the use of the term “natural” in food labeling to mean that nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally …
By Jamie K. Wolszon – FDA published in the July 31, 2012 Federal Register a notice announcing the Fiscal Year (“FY”) 2013 rates pursuant to the third iteration of the Medical Device User Fee Act (“MDUFA III”), which was recently enacted as part of the FDA …
By Kurt R. Karst – Ever since the U.S. Court of Appeals for the First Circuit issued its opinion in May 2012 in Bartlett v. Mutual Pharmaceutical Co., ___ F.3d ___, 2012 WL 1522004 (1st Cir. May 2, 2012) denying Mutual Pharmaceutical Company’s (“Mutual’s”) appeal of …
By Riëtte van Laack – The Animal Drug User Fee Amendments of 2008 (“ADUFA”) directs FDA to prepare and publish annual summaries of antimicrobial animal drugs sold or distributed for use in food-producing animals. The data are derived from information submitted by sponsors of antimicrobial new …
By Riëtte van Laack – The Patient Protection and Affordable Care Act of 2010, in part, amended the FDC Act by adding Section 403(q)(H) requiring restaurants and similar retail food establishments (“SRFEs”) that are part of a chain with 20 or more locations to provide calorie …
