FDA BIOLOGICS THREE-TIERED MANUFACTURING CHANGES CATEGORY SYSTEM BEING ADOPTED BY AGENCY; FDA REFORMS TOUTED BY CLINTON ADMINISTRATION IN PRE-EMPTIVE MOVE
A three-tiered system for biologics manufacturing change reporting similar to that used for drug products is being implemented by FDA through a guideline that will issue "in a matter of days," FDA Deputy Commissioner for Policy William Schultz said at a March 16 trade press briefing.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth