FDA grants Abiomed expanded PMA approval for the Impella 2.5 and Impella CP heart pumps and their use during elective and urgent high risk percutaneou...
Apace Packaging recalls one lot of shingles therapy acyclovir tablets, USP, 400mg, due to a product mix-up.
Federal Register proposed rule: FDA proposes to amend its postmarketing safety reporting regulations for approved new animal drugs to require that cer...
FDA says a petition seeking approval of a generic form of Syprine is moot because the agency has approved an ANDA for the drug.
Stakeholders give FDA a long list of regulations they believe could be modified or eliminated to reduce administrative burden and promote efficiency.
FDA issues a guidance for NDA and ANDA applicants on the regulatory classification of pharmaceutical co-crystals.
PhRMA wants changes in an FDA draft guidance on refusing to file NDAs and BLAs.
Federal Register notice: FDA announces a 3/19 workshop on Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Settings.