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The FDA biomedical innovation hearing featured five witnesses: Susan Winckler from the Reagan-Udall Foundation for the FDA, Aaron J. Kowalski from Breakthrough T1D, Dr. Thomas Hwang from Brigham and Women's Hospital and Harvard Medical School, Dr.…

On July 15, 2026, the House Energy and Commerce Committee held a hearing entitled, Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role in Advancing U.S. Drug Development.

FDA is supporting the development of psychedelic drugs, including new treatments for serious mental health conditions.

The Reagan-Udall Foundation for the FDA and FDA are hosting a hybrid meeting on 5 August to discuss selection criteria and prioritization when considering repurposing drugs for new indications or new populations.

Manufacturing capacity already validated under 21 CFR Part 211 and existing safety dossiers could become strategic assets as the Reagan-Udall Foundation for the FDA convenes a hybrid public meeting on August 5, 2026, to shape how repurposing candidates…

The longevity landscape shifted in May at a landmark public meeting convened by the Reagan-Udall Foundation for the FDA.

According to Crowley, this program was informed by a white paper BIO provided to former FDA commissioner Marty Makary last fall, as well as a subsequent working session with the Reagan-Udall Foundation and top leadership from the FDA’s drug and…

The Blueprint’s four strategic goals are shaped by input from across the animal health community, including findings from the Reagan-Udall Foundation's Transforming Animal Health in the U.S. for the 21st Century report and the AVMA MUMS Roundtable…

This sustained political advocacy culminated in the formal endorsement of the FDA’s new Project Trailblazer initiative, a milestone heavily shaped by collaborative efforts between BIO’s regulatory teams and the Reagan-Udall Foundation in Washington.

The Reagan-Udall Foundation for the FDA just released a new report on strengthening early-stage drug development in the United States.