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