by Marc Kleinman | Mar 29, 2012
An article published this month by Susan J. Schniepp on BioPharm International illustrates the difficulty for contract manufacturing organizations (CMOs) in factoring in the quality priorities and needs of multiple clients into their own planning and operations. The...
by Marc Kleinman | Mar 29, 2012
Last week, the Supreme Court issued a unanimous decision on Mayo Collaborative Services v. Prometheus Laboratories, Inc., in which Mayo had challenged Prometheus’ patent claims covering diagnostic biomarker methods for personalized medicine, specifically as a...
by Marc Kleinman | Mar 22, 2012
Indianapolis-based pharmaceutical giant Eli Lilly signed a deal last week with the National Center for Advancing Translational Sciences (NCATS), providing for Lilly to screen over 3,800 currently approved and investigational new drugs for new potential therapeutic...
by Marc Kleinman | Mar 22, 2012
The Union of Concerned Scientists (UCS) recently conducted a follow-up study to their 2006 survey regarding scientific integrity in the FDA in which FDA scientists pointed to several unsettling issues including the influences of political and special interests in...
by Marc Kleinman | Mar 12, 2012
An article published last week in MassDevice highlights the twists and turns (and resulting consensus) between FDA and medical device industry players in a series of February meetings targeting the medical device user fees program. Among the meetings’ accomplishments,...
