By Kurt R. Karst – Last week when this blogger reported on the lawsuit filed by Amgen, Inc. (“Amgen”) in the U.S. District Court for the Northern District of California alleging that Sandoz Inc. (“Sandoz”), in its efforts to obtain approval of a Section 351(k) application …
By Michelle L. Butler & Kurt R. Karst – On November 3, 2014, just short of the 60-day deadline, FDA filed a notice appealing to the U.S. Court of Appeals for the District of Columbia Circuit the Final Judgment and Order entered on September 5, 2014 …
By Jennifer D. Newberger & Alan M. Kirschenbaum – On October 31, 2014, the Centers for Medicare & Medicaid Services ("CMS") finalized changes to the regulations implementing the Affordable Care Act’s transparency reporting provisions, otherwise known as the Physician Payment Sunshine Act ("Sunshine Act"). The original Sunshine …
By Wes Siegner – In the October 30 Federal Register, FDA announced that it will hold a public meeting on December 9 to consider significant changes to its guidance titled “Toxicological Principles for the Safety Assessment of Food Ingredients,” or “Redbook”. FDA also invited comment to …
By Alexander J. Varond – In one of the clearest signs that the U.S. Consumer Product Safety Commission ("CPSC") is stepping up enforcement of CPSC requirements, the Commission recently announced that it had reached a record $4.3 million civil penalty settlement with Baja Inc., and its …
By Ricardo Carvajal & Riëtte van Laack – FTC filed a complaint in the district court of New Jersey alleging that certain of Gerber’s advertising claims for its hydrolyzed-whey-based infant formula constitute deceptive acts or practices and the making of false advertisements, in violation of the FTC Act. …
By Kurt R. Karst – Ever since the July 2014 announcement by Sandoz Inc. (“Sandoz”) that FDA accepted the first ever application for a biosimilar biological product submitted pursuant to Section 351(k) of the Public Health Service Act (“PHS Act”) – in this case, a biosimilar …
By Jennifer M. Thomas – Around this time last month, we wrote about the government’s motion for an order to show cause in United States v. Bayer, and the potential lessons to be gleaned from that case. Bayer entered into a consent decree with the FTC …
By Allyson B. Mullen & Jeff N. Gibbs – On October 23, 2014, CDRH held a webinar regarding the two Laboratory Developed Tests (LDT) draft Guidance Documents that were released on October 3 (previously blogged on here and here). The webinar began with a high-level description of …
By Ricardo Carvajal - FDA released an online learning module intended “to help the seafood industry, retailers, and state regulators ensure the proper labeling of seafood products offered for sale in the U.S. marketplace.” The learning module consists of three videos that provide an overview of applicable …
By Jeffrey K. Shapiro – FDA has recently finalized the guidance document, now titled “Distinguishing Medical Device Recalls from Medical Device Enhancements.” We were critical of the draft guidance, especially the proposal for a new, extra legal reporting requirement for device enhancements (see our previous post …
By Etan J. Yeshua – Drug developers targeting acute migraines may now have a new path to approval. In a draft guidance document issued on Tuesday by the Division of Neurology Products ("DNP"), FDA offers a novel primary endpoint that has not been used before to …
By Jay W. Cormier & Anne K. Walsh – For managers and employees of drug facilities, the arrival of an FDA inspector can be an anxiety-producing experience. Adding to the understandable nervousness surrounding an inspection is FDA’s new statutory authority to deem drug products adulterated if …
By Ricardo Carvajal – FDA and the Center for Food Safety (CFS) entered into a consent decree that calls for FDA “to submit a final rule regarding ‘Substances Generally Recognized as Safe’ to the Federal Register for publication no later than August 31, 2016.” As we reported in …
By Kurt R. Karst – We were wondering how long it might be until a company went running to FDA to request that the Agency reset the date of approval of its NDA, as well as any unexpired marketing exclusivity, as the result of a proprietary …
