Warning letters, 483s, Recalls, Import Alerts, Audit observations
Novo Nordisk owned Catalent Indiana sterile products formulation facility was inspected by USFDA in June
USFDA has approved Insmed’s Brinsupri (Brensocatib) for Bronchiectasis, a chronic drug disease. The medicinal product
In a blog posted on 8 August 2025, MHRA’s Chris Jones (IAG Chair) and Himal Makwana
The European Commission (EC) has published a draft guidance – Annexure 22 – Artificial Intelligence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
