Regulatory Affairs – Inside ProEd

New FDA Guidance: Accelerated Approval Accountability

ByAaron Csicseri February 4, 2025April 23, 2025

On January 6 and 7, 2025, the FDA released approximately 30 draft or final guidance documents1 covering a wide array of regulatory topics, including: These guidance documents reflect priorities the FDA deems urgent, especially in light of the new administration’s efforts to alter regulatory approaches. This article will focus on the draft guidance updates to…

Artificial Intelligence | FDA | Healthcare innovation | Regulatory Affairs

New FDA Guidance on the Use of AI to Support Regulatory Decisions

ByAaron Csicseri January 28, 2025April 23, 2025

The US Food and Drug Administration (FDA) has just taken a historic step by releasing its first-ever draft guidance on using artificial intelligence (AI) for regulatory decision-making related to the safety, effectiveness, or quality of drugs and biologics.1 Published in January 2025, this framework comes at a pivotal time, as AI’s potential to transform healthcare…