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Second Opinion

Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

AAMC Provides Comments on FDA’s Strategies to Involve Patients in Medical Product Decisions

December 5, 2014—The AAMC December 4 submitted a letter  to the Food and Drug Administration (FDA) in response to a request in the Nov. 4 Federal Register for comments on the agency’s strategies to solicit patient viewpoints through the medical product development process. The FDA is required to solicit these patient perspectives under Section 1137 of the Food and Drug Administration Safety and Innovation Act (FDASIA, P.L. 112-144).

In the comment letter, AAMC acknowledges the FDA’s current efforts to engage patient voices and provide additional recommendations to the FDA, including:

  • To engage with patient advocacy organizations to reach a broader range of patients;
  • To explore methods of contacting patients beyond current approaches; and

  • To evaluate and adapt the strategies as needed.

The AAMC also highlights its previous letter on providing medical product information to patients [see Washington Highlights, Sept. 13, 2013].

Contact:

Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926
Email: hpierce@aamc.org

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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.


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For More Information

Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org