Warning letters, 483s, Recalls, Import Alerts, Audit observations
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The draft guidance Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products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
FDA has published a revised guidance on quality considerations for topical ophthalmic drug products –
The revised monograph for Propylene Glycol (PG) includes test for Ethylene Glycol (EG) and Diethylene
FDA uses Remote Regulatory Assessments (RRAs) to assess compliance of facility with applicable laws and
In the guidance FDA describes use of alternative tools to assess manufacturing facilities identified in
As per the GDUFA III commitment letter, USFDA has issued a draft guidance for facilities
USFDA: Recommended Acceptable Intake Limits for Nitrosamine Drug Substance[1]Related Impurities (NDSRIs) – Guidance for Industry
EMA updates Q&A document on N-Nitrosamines. In the Rev 16 (dated 7 July 2023) limits
