Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

FDA announces GMP guideline for Veterina

The draft guidance Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products

FDA launches new Search page for Quality

USFDA has launched a new search page for Quality documents. The page provides useful links

FDA updates guidance for Reconsideration

This guidance provides procedures for ANDA applicants who wish to pursue a request for reconsideration

FDA revise Quality guidance for Ophthalm

FDA has published a revised guidance on quality considerations for topical ophthalmic drug products –