FDA BIOLOGICAL LOT RELEASE COULD BE HANDLED BY OUTSIDE GROUPS, BIO SAYS; PhRMA DEFINES "BROAD PRINCIPLES" OF FDA REFORM; HIMA WANTS OPTIONAL OUTSIDE REVIEWS
BIO believes FDA could outsource activities in the areas of lot inspections and lot release for biologicals, according to discussions by the association preliminary to development of FDA reform proposals. The Biotechnology Industry Organization board reviewed a series of memos suggesting FDA reforms at its Feb. 8 meeting.
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