By Allyson B. Mullen & Jeffrey N. Gibbs – All this year, FDA had signaled it intended to finalize the guidance for Laboratory Developed Tests (LDTs). On Friday November 18, 2016, FDA abandoned the effort, stating that it will not provide the requisite 60-day notice to Congress …
By Kurt R. Karst – Over the years, we’ve witnessed, learned of, and have even been part of several Orange Book “firsts.” There’s the first listing of patent information covering an old antibiotic drug product (here); the Orange Book note addressing a leap year new chemical …
By Riëtte van Laack – As previously reported, on May 27, 2016, FDA published the final rules regarding nutrition labeling and serving sizes. The amended regulations came into effect on July 26, 2016 and the compliance date is July 26, 2018 for all manufacturers, except for …
By Kurt R. Karst – Last week, FDA filed a Notice of Appeal with the U.S. Court of Appeals for the District of Columbia Circuit appealing a September 9, 2016 Final Judgment and Order from DC District Court Judge Rudolph Contreras concerning Ferring Pharmaceuticals Inc.’s (“Ferring’s”) …
By Riëtte van Laack – As we blogged previously, there have been activities both by FDA and the FTC foreboding a bleak future for homeopathic products. Both FDA and the FTC questioned the policies and standards applicable to homeopathic products. The FTC threatened to hold homeopathic products …
By Alan M. Kirschenbaum & David C. Gibbons – In separate actions implementing the Medicaid Drug Rebate Program (“MDRP”), CMS has delayed for three years the expansion of the MDRP to U.S. Territories, and issued a draft revised National Drug Rebate Agreement. Delay in Expansion to U.S. …
By Jennifer D. Newberger – Though we are certain it was not only our blog post on the draft Medical Device Reporting ("MDR") guidance that persuaded FDA not to adopt some of the positions it proposed in its Draft Guidance, Medical Device Reporting for Manufacturers (July 2013), …
By Ricardo Carvajal – FDA recently announced the issuance of the 7th edition of the Agency's Questions and Answers Regarding Food Facility Registration. The latest edition includes nearly 60 new Q&As on a variety of registration-related topics, including: Biennial registration renewal – A facility’s registration must be renewed in …
Hyman, Phelps & McNamara, P.C. ("HP&M") has once again been ranked as a “Tier 1” law firm in the area of “FDA Law” (both nationally and in Washington, D.C.) by the folks over at U.S. News & World Report, who teamed up with Best Lawyers …
By Kurt R. Karst, John R. Fleder & Robert A. Dormer – The current FDA system to announce hotly contested generic drug approval decisions is broken. As we see it, FDA’s “system” pleases no one and does not appear to be legally mandated. Moreover, whatever advantage …
By Jennifer M. Thomas – Last week, FDA rolled out a new online reporting program, titled “Reporting Allegations of Regulatory Misconduct,” with little fanfare. No blog post in FDA Voice, no press conference, and even the (longwinded) name of the program seems calculated to send the …
By James E. Valentine & Karla L. Palmer – There are a number of lists that are central to FDA’s regulatory framework for the regulation of pharmacy compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetics Act (FD&C Act). In recent posts, …
That will be among several food policy topics discussed this Friday at a Food and Drug Law Journal Symposium titled Law and Food Systems: Institutional Pathways Toward a New Paradigm? Proposals for a single food agency have bubbled up over the years, and the impending election …
Technology continues to change the landscape of healthcare and companies are seeking new and innovative ways to leverage advances in other fields to improve quality of care and the diagnosis and treatment of disease. In doing so, they are required to navigate an increasingly complex …
By Ricardo Carvajal – FDA issued a draft guidance document that addresses disclosures required to be provided by a supplier when certain hazards in food have not been controlled. A disclosure requirement is included in four of the FSMA rules, namely the preventive controls rule for …
