Warning letters, 483s, Recalls, Import Alerts, Audit observations
FDA has announced the over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC
USFDA has updated Safety Communication on Chinese made plastic syringes. FDA had issued a Safety
USFDA Inspectors Anders W. Evenson and Arsen Karapetyan had inspected the Sichuan Deebio facility (FEI
Prospective applicants of Complex Generics (CG) can request for a joint meeting with FDA OGD
Each Drug Establishments (Registrants*) registered with FDA must provide information on amount of each listed
The USFDA announced next phase of the Quality Management Maturity (QMM) Program for drug manufacturers.
The draft guidance Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products
USFDA has launched a new search page for Quality documents. The page provides useful links
This guidance provides procedures for ANDA applicants who wish to pursue a request for reconsideration
FDA has published a revised guidance on quality considerations for topical ophthalmic drug products –
