While we were busy preparing for our Thanksgiving holiday last week, we received the email we had been hoping for: a congratulatory email from the editors of the American Bar Association (“ABA”) Journal announcing that Hyman, Phelps & McNamara, P.C.’s FDA Law Blog was selected …
By Andrew J. Hull* & William T. Koustas – Last week, FDA announced its long-awaited draft guidance to establish standards for the interoperable exchange of information as required by the Drug Supply Chain Security Act (“DSCSA”) (see our previous post here). On November 26th, FDA also released …
By Riëtte van Laack – The Affordable Care Act requires calorie and other nutrition information on menu and menu boards for consumers in chain restaurants and other “similar retail establishments” that sell restaurant-type food. In 2011, FDA issued a proposed rule (see our previous post here). …
By William T. Koustas & Anne Marie Murphy – We have been closely following FDA’s implementation of the Drug Supply Chain Security Act ("DSCSA") (see here and here) and waiting for this day for over a year. As our readers may know, the DSCSA requires certain members …
By Riëtte van Laack – The House of Representatives on Nov. 13 unanimously passed the Senate version of the Sunscreen Innovation Act (SIA), S. 2141. The Act is currently before the President, who is expected to sign it. The SIA amends the Food, Drug, and Cosmetic …
By Jamie K. Wolszon – A battle is brewing between proponents and opponents of FDA’s plans to actively regulate Laboratory-Developed Tests (LDTs), with several developments involving both camps in the past two weeks. On the proponents’ side, on November 21, FDA announced that it will be …
By Ricardo Carvajal - The D.C. District Court granted FDA’s motion for summary judgment in a lawsuit alleging unreasonable delay in the agency’s response to a citizen petition asking for the inclusion of FDA/EPA’s seafood consumption advisory in seafood labeling and at point-of-sale. Although the petition was …
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 James E. Valentine* & Anne Marie Murphy – On November 19, 2014, the National Institutes of Health (“NIH”) announced the much anticipated Notice of Proposed Rulemaking on clinical trials registration and results submission (“NPRM”). While the Food and Drug Administration Amendments Act (“FDAAA”) Section 801 …
By Alexander J. Varond & Anne K. Walsh – On November 17, 2014, FDA announced the availability of its draft guidance entitled, “Rare Pediatric Disease Priority Review Vouchers.” The draft guidance “is intended to assist developers of rare pediatric disease products in assessing whether their product may be …
By Riëtte van Laack – On Nov. 13, 2014, DOJ announced another Consent Decree of permanent injunction regarding the manufacture and distribution of dietary supplements. Under the Consent Decree, contract manufacturer SciLabs, Inc. and its CEO Paul Edalat are prohibited from the manufacture and distribution of dietary …
By Kurt R. Karst – Earlier this week, Mallinckrodt Inc. (“Mallinckrodt”) filed a Complaint and Motion for Temporary Restraining Order (later supplemented) in the U.S. District Court for the District of Maryland challenging FDA’s November 12, 2014 decision to downgrade from “AB” to “BX” the Therapeutic …
By Allyson B. Mullen – Late last week, the Department of Justice ("DOJ") obtained criminal charges from a grand jury sitting in the United States District Court for the Western District of Texas against Vascular Solutions, Inc. ("VSI") and Howard Root, VSI’s CEO, for off-label promotion …
By Michelle L. Butler & Alan M. Kirschenbaum – On November 13, 2014, the Health Resources and Services Administration (“HRSA”) withdrew the 340B program “mega-rule” it had submitted for review to the Office of Management and Budget. In a previous blog post we reported on a …
By Kurt R. Karst – Last Friday, Ranbaxy Laboratories, Ltd. and Ranbaxy, Inc. (“Ranbaxy”) filed a Complaint and a Motion for a Temporary Restraining Order and Expedited Preliminary Injunction in the U.S. District Court for the District of Columbia challenging FDA’s November 4, 2014 Letter Decision …
