Regulatory Affairs
On January 6 and 7, 2025, the FDA released approximately 30 draft or final guidance documents1 covering diverse 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 This article will focus on the draft guidance updates to the accelerated approval…
The US Food and Drug Administration (FDA) has just taken a historic step by releasing its first-ever draft guidance on using artificial intelligence (AI) for regulatory decision-making related to the safety, effectiveness, or quality of drugs and biologics.1 Published in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…
Artificial Intelligence (AI) is significantly transforming pharmaceutical regulatory affairs. Rather than replacing regulatory professionals, AI enhances their capabilities and allows them more time for strategic activities. This blog post explores how AI is revolutionizing the regulatory submission process, the challenges posed by the rapidly evolving AI regulatory landscape, and what regulatory affairs professionals need to…
