Warning letters, 483s, Recalls, Import Alerts, Audit observations
The USFDA has approved Neurocrine Biosciences’ new drug, Crenessity (Crinecerfont), for the treatment of classic
Several lots of the antidepressant drug Duloxetine, manufactured by Aurobindo, India, have been recalled in
The Central Drugs Standard Control Organization (CDSCO) has issued a spurious drug alert for popular
In September 2024, the European Commission (EC) revoked the Conditional Marketing Authorisation (CMA) for Advanz
New Delhi based Unexo Life Sciences has initiated a major recall of several medicated patch
Aurobindo is recalling Cinacalcet tablets in US due to nitrosamine NDSRI impurity N-Nitroso-cinacalcet. Aurobindo has
Chinese OTC Manufacturer Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd was inspected by USFDA in March
USFDA is proposing to remove oral phenylephrine as an active ingredient in over-the-counter (OTC) drug
FDA has published the USFDA Form 483 issued to Novo Nordisk API manufacturing facility at
The USFDA has published a new guidance titled “Review of Drug Master Files in Advance
