FDA describes Benefit-Risk Framework enhancements to be implemented under PDUFA 6.
FDA issues a report outlining plans to develop and then implement new resource capacity planning and modernized time reporting capabilities.
FDA releases an FDA-483 with 11 observations from an agency inspection at SCA Pharmaceuticals in Connecticut.
University of Pittsburgh researchers say that oncology drug indications are approved faster in the U.S. than in several other countries.
Chinese citizen Gao Mei Fang pleads guilty to smuggling and mail fraud charges arising from a scheme to sell mislabeled dietary supplements.
An Arizona federal jury awards a plaintiff $3.6 million in a bellwether case involving C.R. Bards inferior vena cava filter.
FDA grants Proteostasis Therapeutics a fast track designation for its triple combination product for treating cystic fibrosis.
Federal Register Final Rule: FDA amends the animal drug regulations to reflect recent application-related actions for NADAs and ANADAs.