Topic · 3 reports

FDA

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Auchincloss Questions Reagan-Udall Expert on FDA Trial Modernization and Safety Culture Reset

Aug 18, 2026

The clip shows Rep. Jake Auchincloss (D-MA) questioning Ms. Winkler of the Reagan-Udall Foundation during a congressional hearing. Discussion covers overlaps between Reagan-Udall research, HHS Operation TrialBlazer, and Auchincloss's bipartisan draft legislation on point-of-care trials, risk-based testing, and real-world evidence. Winkler addresses consistency in trial design and endpoints. Auchincloss then asks for advice to an incoming FDA commissioner on restoring high safety and efficacy standards after recent staff losses and credibility issues. Winkler emphasizes agency stability, external expert interaction, and early engagement without industry capture.

▶ Source: Forbes Breaking News

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Veasey Questions Verst and Kowalski on Clinical Trial Diversity and FDA Novel Endpoint Safeguards

Aug 18, 2026

Forbes Breaking News clip shows Rep. Marc Veasey questioning witnesses during a July 15, 2026 House Energy and Commerce Subcommittee hearing on FDA's role in biomedical innovation. Veasey asked about expanding clinical trial participation among historically underrepresented communities and safeguards for novel endpoints and biomarkers while preserving evidentiary standards. Dr. Cynthia Verst (IQVIA) discussed recruiting community physicians through interoperable EMR and electronic data capture systems. Dr. Aaron Kowalski (Breakthrough T1D) emphasized a properly staffed FDA, consistent regulations, leading with safety, and clear risk-benefit analysis to support innovation.

▶ Source: Forbes Breaking News

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Guthrie questions experts on FDA psychedelics guidance and clinical trial competitiveness

Aug 15, 2026

Forbes Breaking News aired a segment from a House committee hearing chaired by Rep. Brett Guthrie. The clip shows Guthrie questioning witnesses on FDA collaborations for psychedelics therapies, type 1 diabetes innovations, and maintaining U.S. leadership in clinical trials. Ms. Winkler of the Reagan-Udall Foundation discussed endpoint alignment and recent FDA guidance on psychedelic trials. Dr. Kowalski of Breakthrough T1D highlighted patient advocacy collaboration, and Dr. Verst addressed risks from faster foreign trial activation, particularly in China.

▶ Source: Forbes Breaking News