Warning letters, 483s, Recalls, Import Alerts, Audit observations
FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing
USFDA is proposing to remove oral phenylephrine as an active ingredient in over-the-counter (OTC) drug
The USFDA has published a new guidance titled “Review of Drug Master Files in Advance
The guidance provides information on how FDA decides goal dates for a drug application (ANDA,
The USFDA released draft guidance on New Dietary Ingredient Notification (NDIN) Master Files for dietary
FDA has announced the over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC
Eugia US LLC is recalling one lot of Methocarbamol Injection in US for white particles
USFDA has updated Safety Communication on Chinese made plastic syringes. FDA had issued a Safety
Prospective applicants of Complex Generics (CG) can request for a joint meeting with FDA OGD
USFDA has launched a new search page for Quality documents. The page provides useful links
