By Jeffrey N. Gibbs & Allyson B. Mullen – A new article published on Medical Device and Diagnostic Industry’s (MDDI) website by Hyman, Phelps & McNamara, P.C.’s Jeff Gibbs, Allyson Mullen, and Graematter, Inc’s Melissa Walker, shows that there is more to 510(k) review time statistics …
By Jamie K. Wolszon & Jeffrey N. Gibbs – The House Energy & Commerce Committee, which has jurisdiction over FDA, has issued a “white paper” announcing that as part of its efforts to prepare a draft discussion legislative package in early 2015 related to the overall …
By Alan M. Kirschenbaum – A CMS final regulation implementing changes to the Medicaid Drug Rebate Program (MDRP) is now scheduled to be published in April 2015, according to OMB’s updated current Unified Agenda of Regulatory and Deregulatory Actions. Before you mark that in your calendar …
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 …
By James C. Shehan – Over the past year, the plight of seriously ill patients seeking access to unapproved drugs has led five states to pass laws that permit manufacturers to provide patients in those states with investigational drugs on an emergency basis without going through …
By Kurt R. Karst – 'Tis the season to give back. And that’s exactly what the U.S. Court of Appeals for the Third Circuit did late last week when it vacated and remanded for further proceedings a September 3, 2013 decision from the U.S. District Court …
By Kurt R. Karst – Last Friday, the U.S. Court of Appeals for the Federal Circuit issued its highly anticipated decision in Sandoz Inc. v. Amgen Inc. and Hoffman-La Roche Inc., Case No. 2014-1693 (Fed. Cir. 2014). The case involves two patents Roche licensed to Amgen …
By Kurt R. Karst – As we draw closer to the expected January 2015 release of a discussion draft of legislation marking a high point in the 21st Century Cures Initiative, which was launched earlier this year by Representatives Fred Upton (R-MI) and Diana DeGette (D-CO), …
By Ricardo Carvajal – In tandem with its menu labeling final rule (see our prior posting here), FDA published a final rule that sets out requirements for calorie declaration for foods sold from certain vending machines. In certain respects, the final rule is broader in scope …
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 …
