Generic drug sponsors bear no responsibility for pediatric studies for multisource drugs, the Generic Pharmaceutical Industry Association told FDA in March 3 comments on implementation of FDAMA pediatric exclusivity provisions and the agency's pediatric rule.

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