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PhRMA wants changes in an FDA draft guidance on refusing to file NDAs and BLAs.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.
FDA principal deputy commissioner Rachel Sherman says the agency has to do a better job of preparing the next generation of staff leaders to take over...