Warning letters, 483s, Recalls, Import Alerts, Audit observations
The guidance provides information on how FDA decides goal dates for a drug application (ANDA,
The revised EDQM guideline “Content of the dossier for chemical purity and microbiological quality of
The USFDA released draft guidance on New Dietary Ingredient Notification (NDIN) Master Files for dietary
FDA has issued a new guidance for handling reserve samples from bioavailability (BA) and bioequivalence
EMA(Europeans Medicines Agency) has updated the Appendix 1 Acceptable intakes established for N-nitrosamines with 15
USFDA has issued a new guidance for primary batches to be included in the CMC
European Pharmacopoeia Commission (EPC) approved the new strategy for N-nitrosamine impurities in individual monographs in
Each Drug Establishments (Registrants*) registered with FDA must provide information on amount of each listed
The draft guidance Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products
This guidance provides procedures for ANDA applicants who wish to pursue a request for reconsideration
