FDA’s Theresa Mullin, Compassionate Use Advisory Committee, and Cystic Fibrosis Foundation to be Honored with Innovations in Regulatory Science Awards 

Honorees to be recognized on December 11 in Washington, DC

Washington, DC - The Reagan-Udall Foundation for the FDA will present 2019 Innovations in Regulatory Science Awards to Theresa M. Mullin, PhD, of the FDA’s Center for Drug Evaluation and Research; the Compassionate Use Advisory Committee, a collaborative program of Johnson & Johnson and New York University; and the Cystic Fibrosis Foundation.

The Reagan-Udall Foundation for the Food and Drug Administration has named Dr. Adrian F. Hernandez to its Board of Directors.

The Reagan-Udall Foundation for the FDA seeks nominations for key positions on its Steering Committee. Comprised of 12 members, the IMEDS Steering Committee provides oversight and guidance on the operation of IMEDS by advising on strategic direction, helping to integrate IMEDS within the research community, and providing input on IMEDS program activities.

Join leaders in the regulatory field on December 11, 2019, to honor leaders and innovators making a significant impact on America's public health.

6 p.m. - 9 p.m.
The Mayflower Hotel 
1127 Connecticut Avenue NW
Washington, DC 20036

Meet our 2019 honorees and purchase tickets here.

Sponsorship opportunities are still available. Contact lmcnee@reaganudall.org

Join us for an interactive two-day workshop to discuss challenges around repurposing drugs that are already on the market but lack commercial and regulatory incentives for further research and development.

The U.S. Food and Drug Administration (FDA) plans to provide oncologists with greater help in acquiring expanded access to investigational therapies. Deemed Project Facilitate, the pilot program was announced at a press briefing during the 2019 ASCO Annual Meeting.

Project Facilitate is essentially a call center that will be run by the FDA Oncology Center of Excellence. It’s a single point of contact where FDA oncology staff will help oncology providers submit an expanded access request for an individual patient.

The US Food and Drug Administration (FDA) on Monday launched a new pilot program, dubbed Project Facilitate, aimed at helping physicians complete expanded access requests for cancer patients.
 

FDA's Oncology Center of Excellence and the Reagan-Udall Foundation launched Expanded Access Navigator and Project Facilitate, two separate but coordinated pilot programs to provide patients and physicians with expanded access to oncology drugs. The launches came Monday at the American Society of Clinical Oncology (ASCO) meeting in Chicago.

Embargoed until 9 a.m. EDT June 3, 2019

Media Inquiries: Lea Ann Browning-McNee, 301-509-1846

Consumer/Provider Inquiries: 202-849-2075

Expanded Access Navigator Improves Patient Access to Investigational Therapies

New enhancements make it easier for patients, caregivers and healthcare providers to find crucial information