Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA: Recommended Acceptable Intake Limits for Nitrosamine Drug Substance[1]Related Impurities (NDSRIs) – Guidance for Industry
Zurzuvae (zuranolone), the first oral medication to treat postpartum depression (PPD) in adults. PPD is a
The GDUFA fee rates show steepest increase for DMF by 21% to $94,682 from $78,293.
Intas facility was inspected by FDA investigators Jose E Melendez, Justin A Boyd, Pratik S
Lupin recalls 4179 boxes of Tydemy. Tydemy is Drospirenone, Ethinyl Estradiol & Levomefolate Calcium Tablets
Tarsus Pharmaceuticals Inc., in a statement announced FDA approval of Lotilaner ophthalmology solution 0.25% (XDEMVYâ„¢).
Verrica Pharmaceuticals Inc. is a dermatology therapeutics company developing medications for skin diseases requiring medical
EMA updates Q&A document on N-Nitrosamines. In the Rev 16 (dated 7 July 2023) limits
