The Food and Drug Law Institute (FDLI) is holding a two day conference, titled “Enforcement, Litigation, and Compliance conference.” The workshop is this week, on December 9 and 10. Within the conference, Jeff Shapiro will participate in a medical device breakout panel focused on mHealth …
By Jay W. Cormier & Allyson B. Mullen – Two years ago, FDA promulgated the Part 4 regulations that specify how manufacturers of combination products are to comply with current good manufacturing practice (cGMP) when making products whose constituent parts are from more than one type …
By Andrew J. Hull* & William T. Koustas – Piece by piece, FDA has been releasing guidance documents to implement the Drug Supply Chain Security Act (“DSCSA”). As we reported last week (see our previous post here), FDA created a database to allow wholesale drug distributors …
On Wednesday, December 3rd, the Food & Drug Law Institute and the University of Maryland Schools of Law and Pharmacy will hold a conference on “Emerging Issues in FDA Law: Implementation of DQSA” in Washington, D.C. The conference will include updates on implementation of …
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By William T. Koustas – FDA has issued a new draft guidance titled “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” (Draft Guidance). This Draft Guidance is the first of many to come in FDA’s implementation of the Drug Supply Chain Security …
By Anne K. Walsh – Late last Friday afternoon, FDA issued a new guidance document describing FDA’s recommended practices for distributing reprints that convey new risk information for approved drug and biologic products. The guidance defines “new risk information” as information that becomes available after a …
By Kurt R. Karst – When we first heard about the Complaint and Motion for Preliminary Injunction Zogenix, Inc. filed against Massachusetts Governor Deval Patrick, among others, alleging that the Commonwealth’s ban on FDA-approved ZOHYDRO ER (hydrocodone bitartrate) Extended-release Capsules is unconstitutional because the ban …
By Kurt R. Karst – Since we started this blogging gig seven years ago (March 6th was our anniversary) we’ve strived to cover topics of interest to FDA-regulated companies, fellow food and drug and healthcare lawyers and regulatory personnel, as well as people just generally interested …
By Riëtte van Laack – In March 2013, the nearly three-year battle between POM Wonderful and the FTC that was fought at the FTC moved to the United States Court of Appeals for the D.C. Circuit (see our previous posts here and here). Following several extensions …
By Kurt R. Karst – When the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. v. Bartlett (Docket No. 12-0142) on June 24th, ruling that state-law design-defect claims that turn on the adequacy of a drug’s warnings are preempted by the FDC …
By Jennifer D. Newberger – It is not often that CDRH guidance documents get much attention outside the trade press and medical device circles. So when The Wall Street Journal and The Washington Post both publish articles about a draft guidance document on the same day, …
By David B. Clissold – FDA has released a Draft Guidance for Industry, titled “Abuse-Deterrent Opioids—Evaluation and Labeling.” Since at least 2005, Congress has noted the need for FDA guidance governing the development and approval of abuse-deterrent drug products. See e.g., H.R. Rep. No. 109-102 (2005) (here …
By Riëtte van Laack – As we anticipated, both the FTC Staff and POM Wonderful appealed the May 17, 2012 Initial Decision by the FTC’s Administrative Law Judge (ALJ). Among other things, the FTC Staff appealed the ALJ’s conclusion that substantiation of disease efficacy claims does …
By Alan M. Kirschenbaum & Nisha P. Shah – In the December 19, 2011 Federal Register, CMS published a long-awaited proposed regulation to implement the transparency report requirements of the Patient Protection and Affordable Care Act. Hyman, Phelps & McNamara, P.C. has prepared a summary of …
