Warning letters, 483s, Recalls, Import Alerts, Audit observations
Amid all the ongoing Tariff Turf War, the U.S. Food and Drug Administration (FDA) has
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
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
USFDA has issued the final guidance for Pre-Submission Facility Correspondence (PFC) for prioritised generic drug
The USFDA issued a notification on 22 May, 2025 on Data Integrity concerns on reliability
The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs
The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Qfitlia (fitusiran) for the treatment
Indian API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in
