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FDA releases the form FDA-483 with three observations from an inspection at Biocon Biosphere in Andhra Pradesh, India.[ Price : $8.95]
Pfizer plans to discuss with FDA its path to seek approval of its investigational gene therapy for treating adults with moderately...[ Price : $8.95]
Federal Register notice: FDA announces that it revoked a Mesa Biotech emergency use authorization for the Accula SARS-CoV-2 Test.[ Price : $8.95]
FDA establishes a docket to receive information and comments on how best to advance the development of new biosimilar biological p...[ Price : $8.95]
FDA publishes a guidance on assessing types of medical records to provide real-world data (RWD) for drugs and biologics regulatory...[ Price : $8.95]
FDA publishes a guidance with recommendations for reporting categories and the content of postapproval change submissions about gl...[ Price : $8.95]
Attorney Julie Tibbets reviews the Warning Letters issued in FY 2023 and so far in FY 2024 under the FDA Bioresearch Monitoring pr...[ Price : $8.95]
FDA denies a Novartis 2022 petition seeking specific agency actions on ANDAs citing Entresto as the reference-listed drug.