Day: May 14, 2026

For decades, pregnant women have remained one of the most systematically excluded populations in pre-approval clinical development programs. As a result, many therapeutics enter the market with limited or no human pregnancy safety data despite anticipated real-world exposure shortly after commercialization. FDA’s May 2026 guidance, Postapproval Pregnancy Safety Studies, represents a significant evolution in regulatory expectations for pregnancy pharmacovigilance and real-world evidence generation. … Read more

The integration of generative AI into clinical workflows has triggered a “shadow IT” movement, where practitioners leverage unvetted Large Language Models (LLMs) to manage increasing administrative burdens without official institutional oversight. While platforms like OpenEvidence offer high-velocity access to peer-reviewed literature, the lack of transparency in these non-deterministic systems creates a significant “black box” liability. Regulatory professionals … Read more