Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA announced it has awarded 10 new clinical trial studies through Orphan Products Grants Program
The electronic platform for processing Prequalification Information of Medicines – ePQs will enable manufacturers, National
SCYNEXIS issued the recall of 2 lots of BREXAFEMME (ibrexafungerp tablets) due to Potential for
Fabre-Kramer Pharmaceuticals Inc. (Fabre-Kramer), a biopharmaceutical company announced approval of Exxua™ (gepirone hydrochloride extended-release tablets)
Florida based VistaPharm LLC is recalling in US one lot of ulcer treatment drug Sucralfate
In the guidance FDA describes use of alternative tools to assess manufacturing facilities identified in
FDA has raised concerns about therapeutic equivalence of Tacrolimus capsules of Accord Healthcare to brand
Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL is indicated for the prophylaxis of
Abbot recalls all batches of Digene Gel of all flavours (Mint, Orange, Mix fruit flavours)
USFDA has eliminated the REMS for Lotronex (alosetron hydrochloride) and approved generics. Alosetron hydrochloride is
