- Indian generic drugmaker gets FDA warning over clinical study consentIndian generic drugmaker Alembic Pharmaceuticals has been hit with an FDA warning letter after failing to get informed consent from patients for a clinical study. In a breakaway from typical FDA…Endpoints · 3d ago↗ source
- Biotech industry leaders file brief backing FDA against ‘malicious’ mifepristone challengeA group of 61 biopharma companies, executives and investors has filed an amicus brief in support of the FDA in an ongoing case brought by Louisiana meant to remove access to the abortion pill mifep…Fierce Biotech · 3d ago↗ source
- FDA plans to name permanent center heads alongside FDA chiefThe FDA is planning to announce a slate of senior personnel announcements when a new commissioner is named, including permanent heads of CBER and CDER, according to three sources familiar with the…