FDA releases the form FDA-483 with three observations from an inspection at Biocon Biosphere in Andhra Pradesh, India.
Pfizer plans to discuss with FDA its path to seek approval of its investigational gene therapy for treating adults with moderately severe to severe he...
Federal Register notice: FDA announces that it revoked a Mesa Biotech emergency use authorization for the Accula SARS-CoV-2 Test.
FDA establishes a docket to receive information and comments on how best to advance the development of new biosimilar biological products through guid...
FDA publishes a guidance on assessing types of medical records to provide real-world data (RWD) for drugs and biologics regulatory decision-making.
FDA publishes a guidance with recommendations for reporting categories and the content of postapproval change submissions about glass container closur...
Attorney Julie Tibbets reviews the Warning Letters issued in FY 2023 and so far in FY 2024 under the FDA Bioresearch Monitoring program.
FDA denies a Novartis 2022 petition seeking specific agency actions on ANDAs citing Entresto as the reference-listed drug.
