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.
FDA accepts for filing a Telix Pharmaceuticals NDA for TLX007-CDx, a proprietary cold kit for preparing prostate-specific membrane antigen-PET imaging...
FDA posts a final guidance entitled Providing Over-the-Counter Monograph Submissions in Electronic Format.
FDA warns Vietnams Yahon Enterprise about CGMP violations in its manufacturing of finished drugs.
