Drugs

Integrating Randomized Trials and Real-World Data

Biostatisticians from FDA and several universities say interest in integrating randomized clinical trials (RCTs) with real-world data (RWD) continues to grow as stakeholders seek evidence that is both internally valid and relevant to clinical practice. Writing in an open-source article in Clinical Pharmacology & Therapeutics, the researchers say, “Principled integration of RCTs and RWD, grounded in explicit causal frameworks, offers a path toward evidence that is both internally credible and externally relevant.” They say the article describes distinct objectives for the integration of RCTs and RWD and discusses how those objectives shape key design and analytic considerations.

TAP Pilot Has 159 Enrolled Devices

FDA says that as of 10/7, there are 159 medical devices enrolled in the Total Product Life Cycle Advisory Program (TAP) pilot. An online update also says that on 7/1, TAP expanded to accept enrollment requests across all Offices of Health Technologies for Breakthrough-designated and Safer Technologies

FDA, NIH Working to Cut Animal Testing

FDA and the National Institutes of Health (NIH) are “working together extremely closely” in the effort to reduce animal testing for drugs. That’s the report of NIH deputy director for program coordination, planning, and strategic initiatives Nicole Kleinstreuer, who said, “I think what we’re seeing is an unprecedented

Analysis Sees More Depth, Specificity in FDA Drug Inspections

A review of 42,192 observations from 8,663 inspections conducted between 2008 and 2026, as shown on the FDA inspection dashboard, found that 2026 does not represent a wholesale shift in FDA inspection priorities. Rather, according to regulatory consultant Jeffrey Palmer, writing in an online post, it reflects intensified

FDA AI Office Faces Test Turning Policy Into Practical Rules

FDA’s decision to establish its new Office of Innovation and Clinical Trial Modernization (OICTM) and form dedicated divisions for artificial intelligence (AI) and real-world evidence (RWE) analytics (see earlier story) could provide drug developers with a clearer regulatory pathway for emerging technologies, but the agency now faces the

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TAP Pilot Has 159 Enrolled Devices

FDA, NIH Working to Cut Animal Testing

Analysis Sees More Depth, Specificity in FDA Drug Inspections

FDA AI Office Faces Test Turning Policy Into Practical Rules