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.
Hikma Pharmaceuticals extends a Class 1 recall of one lot of acetaminophen injection, 1,000mg/100mL due to the potential presence of a bag labeled dex...
Federal Register notice: FDA extends the comment period on its 6/26-released Information Technology (IT) Strategy and Customer Experience Strategy....
Federal Register notice: FDA announces that OMB has approved an information collection entitled Survey on Quantitative Claims in Direct-to-Consumer Pr...
