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DIA 2019 Global Annual Meeting in San Diego
Sharpless Calls for a Nimble, Flexible, More Efficient US FDA - Pinksheet
"Sharpless said FDA's organization also must ensure collaboration across disciplines and locations, as well as with outside groups. In a speech to the Reagan-Udall Foundation annual meeting later in the day, though, he acknowledged that outside collaborations are often challenging for FDA."
Sharpless Begins to Learn the Ropes While FDA Center Directors Look to the Future
Read Zach Brennan’s reference to the Foundation's Annual Public Meeting in his Regulatory Focus™ article: “Sharpless Begins to Learn the Ropes While FDA Center Directors Look to the Future”
Wasser Departs Reagan-Udall Foundation for the FDA
June Wasser Departs Reagan-Udall Foundation for the FDA
Amar Bhat, PhD, named Interim Executive Director
Project Facilitate: Enhancing the Single Patient IND Process for Oncology
May 16, 2019 | 1:00 PM to 3:30 PM
FDA White Oak Campus Building 31, Room 1503 - Great Room
10903 New Hampshire Avenue, Silver Spring, MD 20993
Call for Nominations: Innovations in Regulatory Science Awards
Reagan-Udall Foundation for the Food and Drug Administration is seeking nominations through June 14, 2019, for its third annual Innovations in Regulatory Science Awards. These Awards honor outstanding achievements of individuals and organizations that have made distinguished contributions to regulatory science and policy.
Award Categories
The Awards will be presented in three categories this year. Full criteria is detailed in the nomination form (download below).
2019 Annual Public Meeting
Annual Public Meeting Set for May 2, 2019
Each year, the Foundation conducts an annual public meeting to discuss its activities and support of the U.S. Food and Drug Administration. The 2019 Annual Public Meeting will focus on pressing FDA initiatives suitable for Public-Private Partnerships and will be held from 10 a.m. until noon on May 2, 2019, at the following location:
PEW Charitable Trust
901 E Street, NW, Suite 1700
Washington, DC 20004
Report on Leveraging Real-World Treatment Experience from Expanded Access Protocols
Learn about strategies for Leveraging Real-World Treatment Experience from Expanded Access Protocols in the report from our November public meeting at the FDA White Oak Campus. We brought all the stakeholders together --- patient advocates, physicians, industry and regulators --- for input.
Updated FDA Guidance on Expanded Access
The FDA updated its guidance to clarify that listing in our Expanded Access Navigator Company Directory satisfies the 21st Century Cures Act requirement of making EA policies readily available. Read "How should we post our expanded access policy?" for detail.