[ Price : $8.95]
FDA denies a Novartis 2022 petition seeking specific agency actions on ANDAs citing Entresto as the reference-listed drug.[ Price : $8.95]
FDA accepts for filing a Telix Pharmaceuticals NDA for TLX007-CDx, a proprietary cold kit for preparing prostate-specific membrane...[ Price : $8.95]
FDA posts a final guidance entitled Providing Over-the-Counter Monograph Submissions in Electronic Format.[ Price : $8.95]
FDA warns Vietnams Yahon Enterprise about CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
Hikma Pharmaceuticals extends a Class 1 recall of one lot of acetaminophen injection, 1,000mg/100mL due to the potential presence ...[ Price : $8.95]
Federal Register notice: FDA extends the comment period on its 6/26-released Information Technology (IT) Strategy and Customer Exp...[ Price : $8.95]
Federal Register notice: FDA announces that OMB has approved an information collection entitled Survey on Quantitative Claims in D...[ Price : $8.95]
Three stakeholders provide requested input to FDA on the risks and benefits of non-device software functions.