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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FDA advisory committee recommends six peptides for compounding pharmacies

Jul 25, 2026

ABC News reports on an FDA Pharmacy Compounding Advisory Committee meeting reviewing seven peptides for possible addition to the 503A Bulks List, which would allow licensed compounding pharmacies to manufacture them for prescription use. The segment notes current gray-market access via social media for substances like BPC-157 and TB-500, their lack of clinical trials or FDA approval, and physician concerns over safety and efficacy data. The report states the panel voted in favor of making some peptides more accessible despite FDA scientists' advice against it, with the final decision resting with FDA leadership. It references the advisory nature of the vote and the substances' typical overseas sourcing for research purposes only.

▶ Source: ABC News