Warning letters, 483s, Recalls, Import Alerts, Audit observations
The European Commission (EC) has published a draft guidance – Annexure 22 – Artificial Intelligence
USFDA has issued a Warning letter to Glenmark Pharma’s Pithampur manufacturing facility (FEI 3008565058). The
China’s rise in cutting-edge pharmaceutical innovation received a major fillip with the USFDA approval of
USFDA has published over 200+ redacted Complete Response Letters (CRLs) issued to drug applicants. The
USFDA has allowed drug manufacturers additional time for submission of mitigation actions and required changes
Indian drug regulator CDSCO has published the Not of Standard Quality (NSQ) alert lists for
USFDA has issued the final guidance for Pre-Submission Facility Correspondence (PFC) for prioritised generic drug
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter in June 2025
The USFDA issued a notification on 22 May, 2025 on Data Integrity concerns on reliability
Indian regulatory agency, CDSCO has updated the requirements for application and issuance of Export NOC
