FDA Generic Biologics “Structure” To Come Soon; Policy Debate In 2005
Executive Summary
FDA hopes to be in a position to kick off a legislative and policy debate on the feasibility of "follow-on" biologics by the beginning of 2005
You may also be interested in...
FDA Nominee Is Crawford: Choice Emphasizes Continuity, Cooperation
The Bush Administration's announcement that it intends to nominate Lester Crawford to be permanent FDA commissioner means that the pharmaceutical industry can count on continuity heading into the renewal process for the prescription drug user fee program
FDA Nominee Is Crawford: Choice Emphasizes Continuity, Cooperation
The Bush Administration's announcement that it intends to nominate Lester Crawford to be permanent FDA commissioner means that the pharmaceutical industry can count on continuity heading into the renewal process for the prescription drug user fee program
“Follow-On” Biologics Guidance Will Limit Use Of Data To “Public Domain”
FDA's upcoming draft guidance on follow-on biologics will allow use of data that are in the public domain only, Center for Drug Evaluation & Research acting Director Steven Galson, MD, told the Schwab Soundview Washington Research Group health care conference May 5