Warning letters, 483s, Recalls, Import Alerts, Audit observations
In an Interview to CNBCTV18 during visit to India, USFDA Commissioner touched on different topics
The Section 5200.14 of the Manual of Policies and Procedures (MAPP), Filing Review of Abbreviated
Hospira recalled in US one lot of 4.2% Sodium bicarbonate injection and one lot each
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
