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- CDER plans new guidance on AI, electronic safety report submissions, and moreThe 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 new…
- Stakeholders urge FDA to create drug-repurposing framework that avoids disincentives and stays within authorityStakeholders, including patients and healthcare industry groups, told the FDA that repurposing existing drugs offers significant opportunities for new treatments. They warned that any new repurpos…