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.
CDRH director Jeff Shuren says he is retiring later this year and deputy Center director for transformation Michelle Tarver will serve as acting direc...
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...
