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The CDER Office of Prescription Drug Promotion says an Amneal patient brochure for its Avastin biosimilar Alymsys is false or misl...[ Price : $8.95]
Minutes of the 3/10 and 3/12 PDUFA 8 reauthorization steering committee sessions, progress was reported on the America First fee i...[ Price : $8.95]
Granules India Ltd tightens oversight of its manufacturing operations at its largest facility based on FDA-documented compliance i...[ Price : $8.95]
FDA cites GMP deficiencies at a facility operated by Thermo Fisher Scientific (Patheon Italia unit) in Ferentino, Italy.[ Price : $8.95]
FDA removes partial clinical hold against MacroGenics Phase 2 LINNET study evaluating the investigational cancer therapy lorigerli...[ Price : $8.95]
An FDA Matters column calls on FDA to fully enforce the laws against mass compounding of approved drugs that are not in shortage.[ Price : $8.95]
Law firm Sheppard breaks down some of FDAs proposals in its budget documents that industry should keep a close eye on, including n...[ Price : $8.95]
FDA announces a 5/18 virtual public workshop aimed at advancing the use of novel surrogate endpoints in developing treatments for ...