By Kurt R. Karst – There’s no two ways about it: We love data. And it doesn’t really matter what FDA-related topic those data concern: citizen petitions (here and here), drug patent settlement agreements (here), user fees (here), orphan drugs (here), or just general FDA regulation …
Attached here is the obituary of Frank Hurley, as issued by his company RRD International. Frank was a Co-Founder of RRD as well as its Chairman and Chief Scientific Officer. The obituary’s rich detail correctly describes his professional reputation as the premier innovator in his …
By James E. Valentine* & Anne Marie Murphy – The first month of 2015 has seen two policy proposals that would expand clinical trials data sharing. On January 14, the Institute of Medicine (“IOM”) released its report on “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks,” …
By Karla L. Palmer – A very busy House Energy and Commerce’s Subcommittee on Health (chaired by Joe Pitts (R-PA)) held a hearing earlier this week to review six bi-partisan bills intended to benefit veterans, address the prescription drug abuse crisis, secure access to medical care, and improve certain …
By Jennifer D. Newberger – The question of what constitutes an accessory has never been well answered. In a December 1996 guidance document, Medical Device Quality Systems Manual: A Small Entity Compliance Guide, FDA said that accessory devices are devices “packaged, labeled, and distributed separately to a …
By Kurt R. Karst – For months we have been waiting with bated breath for the promised January 2015 release of a discussion draft of legislation to implement the 21st Century Cures Initiative, which was launched in April 2014 by now-Chairman of the House Energy and …
By Kurt R. Karst – Earlier today (January 26, 2015), FDA announced the first approval of an ANDA for a generic version of AstraZeneca Pharmaceuticals LP's (“AstraZeneca's”) NEXIUM (esomeprazole magnesium) Delayed-Release Capsules, 20 mg and 40 mg. But it wasn’t Ranbaxy Laboratories, Ltd./Ranbaxy, Inc. (“Ranbaxy”) that scored …
By Kurt R. Karst – It’s been a little more than 2.5 years since Section 505(w) was added to the FDC Act by Section 1134 of the 2012 FDA Safety and Innovation Act (“FDASIA”). Section 505(w), titled “Deadline For Determination on Certain Petitions,” requires FDA to …
By Anne K. Walsh – This post relates to the all-important package insert, which provides health care professionals with the latest information about the approved uses of a prescription drug or biological product, as well as information necessary for the safe and effective use of the …
By Kurt R. Karst – When Judge Ketanji Brown Jackson of the U.S. District Court for the District of Columbia noted in a January 12, 2015 Minute Order that the Court filed under seal a “lengthy opinion” on January 9, 2015 denying Motions for Summary Judgment …
By Jennifer D. Newberger – FDA has historically taken the position that products intended to benefit a user’s overall health and wellness, and that did not make claims about disease prevention, treatment, mitigation, or cure, would not be regulated as medical devices. For example, in 1995, …
By Riëtte van Laack – As we previously reported, the Farm Bill of 2014 tasked the Agricultural Marketing Service (AMS) with the preparation of a report regarding the need for a federal standard of identity for honey. Without much fanfare, AMS recently published its report to …
By Kurt R. Karst – The news came down on Thursday that FDA’s Center for Drug Evaluation and Research Director Janet Woodcock, M.D., named Kathleen “Cook” Uhl, M.D., as the permanent director of the Office of Generic Drugs (“OGD”). Although Dr. Uhl has manned the helm at OGD …
By Riëtte van Laack – According to an FTC Complaint, filed in the United States District Court for the Northern District of Illinois, the advertising practices of NourishLife, an Illinois Company, and its owner, Mark Nottili, (“Defendants”) violated the FTC Act. The FTC alleges that Defendants …
By Kurt R. Karst – A little over three months ago, we on a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction Takeda Pharmaceuticals U.S.A., Inc.’s (“Takeda”) filed against FDA in the U.S. District Court for the District of Columbia challenging the …
