Category: Guidance

FDA issues draft guidance for Dietary In

The USFDA released draft guidance on New Dietary Ingredient Notification (NDIN) Master Files for dietary

FDA Issues guidance for Handling and Ret

FDA has issued a new guidance for handling reserve samples from bioavailability (BA) and bioequivalence

EMA Updates list of N-Nitrosamines

EMA(Europeans Medicines Agency) has updated the Appendix 1 Acceptable intakes established for N-nitrosamines with 15

USFDA issues guidance for Animal Drug Ap

USFDA has issued a new guidance for primary batches to be included in the CMC

EDQM New strategy for N-nitrosamine impu

European Pharmacopoeia Commission (EPC) approved the new strategy for N-nitrosamine impurities in individual monographs in

FDA issues final guidance for annual rep

Each Drug Establishments (Registrants*) registered with FDA must provide information on amount of each listed

FDA announces GMP guideline for Veterina

The draft guidance Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products

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 –

Ph.Eur pre-publishes revised monograph f

The revised monograph for Propylene Glycol (PG) includes test for Ethylene Glycol (EG) and Diethylene