Warning letters, 483s, Recalls, Import Alerts, Audit observations
Under a new trade deal, the U.S. government is bringing down tariffs on generic drugs
The USFDA issued a Warning letter to Amneal Pharmaceuticals following critical deviations observed during an
Government of India has published the Gazette notification to make disclosure of Qualitative details of
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The European Commission (EC) has published a draft guidance – Annexure 22 – Artificial Intelligence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
