- CDER plans new guidance on AI, electronic safety report submissions, and more<p>The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four…raps · 12d ago↗ source
- Drug repurposing: Stakeholders say FDA should act within its authority, avoid disincentives<p>Patient and healthcare industry stakeholders told the US Food and Drug Administration (FDA) that while there are significant opportunities to repurpose existing drugs, the agency should ensure a…raps · 12d ago↗ source
- FDA acting chief walks back Makary's practice of policymaking through journalsThe FDA is continuing to rewind actions by former Commissioner Marty Makary, saying that two medical journal articles published over the last year did not constitute agency policy. The about-face…