FDA Rush To Create Pediatric Drug List Compromised Policy - Generic Firms
FDA's push to meet the statutory deadline for its pediatric list did not permit adequate public input and resulted in too broad a list of drugs for which innovator companies may gain exclusivity, generic groups asserted in a lawsuit filed in D.C. federal court Feb. 19.
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