Warning letters, 483s, Recalls, Import Alerts, Audit observations
The USFDA released draft guidance on New Dietary Ingredient Notification (NDIN) Master Files for dietary
Glenmark has initiated a recall of one lot of Diltiazem Hydrochloride 120mg, Extended Release(ER) Capsules
FDA has announced the over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC
FDA approved Akebia’s Vafseo (Vadadustat) for treatment of anaemia due to Chronic Kidney Disease (CKD)
FDA has approved Merck’s Biologic drug Winrevair (Sotatercept-CSRK) for Pulmonary Arterial Hypertension (PAH). The product
Eugia US LLC is recalling one lot of Methocarbamol Injection in US for white particles
FDA has issued a new guidance for handling reserve samples from bioavailability (BA) and bioequivalence
USFDA has approved Italfarmaco’s Duvyzat (givinostat) oral medication for treatment of Duchenne Muscular Dystrophy (DMD).
USFDA has approved Idorsia’s new drug Tryvio, a New Molecular Entity (NME) drug Aprocitentan for
EMA(Europeans Medicines Agency) has updated the Appendix 1 Acceptable intakes established for N-nitrosamines with 15
