[ Price : $8.95]
The CDER Office of New Drugs publishes a MAPP on the regulatory basis for refusing to file an NDA, sNDA, BLA, or sBLA.[ Price : $8.95]
FDA publishes the checklists used by CDER reviewers to determine if an NDA or BLA can be accepted for filing.[ Price : $8.95]
Alector discontinues development of latozinemab for treating a rare genetic form of frontotemporal dementia after a Phase 3 trial ...[ Price : $8.95]
FDA warns Chinas Foshan Yiying Hygiene Products Co. about CGMP issues in its production of over-the-counter drugs.[ Price : $8.95]
FDA warns Chinas Dongguan Rainbow Tech Electronic & Plastics Co. about Quality System Regulation violations in its manufacturing o...[ Price : $8.95]
The Senate Special Committee on Aging releases a report with six recommendations for reducing the use of foreign-made drugs for se...[ Price : $8.95]
FDA commissioner Marty Makary addresses during a podcast the agencys significant shift in enforcement policy directed at pha...[ Price : $8.95]
A South Carolina newspaper reports that the latest FDA inspection at Nephron Pharmaceuticals found the company still has significa...