Warning letters, 483s, Recalls, Import Alerts, Audit observations
In December 2024, the Indian drug regulator, CDSCO, flagged 51 drugs as Not of Standard
The USFDA issued a warning letter in January 2025 to Sanofi’s API facility in Framingham,
The FDA has issued new guidance on “Considerations for Complying With 21 CFR 211.110.” According
Indoco Remedies’ Goa Plant (FEI 3005124189) received a warning letter from the FDA following critical
The USFDA has issued a Warning Letter to Hyderabad-based OTC manufacturer Akron Formulations for critical
The Indian drug regulator, CDSCO, has published a list of spurious drugs detected in November
Adding to the growing number of drug recalls due to NDSRIs in 2024, Glenmark is
The USPTO is withdrawing the proposed new rule which was published in the Federal Register
USFDA has approved Checkpoint Therapeutics Cosibelimab-ipdl (Unloxcyt) for treatment of skin cancer CSCC (metastatic cutaneous squamous
The USFDA has approved Neurocrine Biosciences’ new drug, Crenessity (Crinecerfont), for the treatment of classic
