By Kurt R. Karst – In a letter recently submitted to FDA by the three principal authors of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) – Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton (R-TX) – the legislators take issue with …
Hyman, Phelps & McNamara, P.C. (“HPM”) is pleased to announce that Anne K. Walsh has joined the firm as Of Counsel. Prior to joining the firm in January 2011, Ms. Walsh served as an Associate Chief Counsel with the U.S. Food and Drug Administration’s Office …
By Jeffrey K. Shapiro – A group of nine U.S. Senators has sent a letter to FDA expressing concern over potential changes to the 510(k) medical device clearance program. The letter is similar to a November 2010 letter from Minnesota lawmakers and an October 2010 letter …
By Diane B. McColl & Ricardo Carvajal – On December 28th, FDA reopened the public comment period for its 1997 proposed rule that outlined the voluntary GRAS notification process intended to replace the voluntary GRAS affirmation petition process. FDA stopped accepting GRAS affirmation petitions and implemented …
By Cassandra A. Soltis – The Food and Drug Administration (“FDA”) posed that question in 2005, when it issued an advance notice of proposed rulemaking concerning the serving sizes of products that could reasonably be consumed at one eating occasion. 70 Fed. Reg. 17010 (Apr. 4, …
