![Caretaker pushing older man in a wheelchair from behind](https://www.brookings.edu/wp-content/uploads/2024/07/shutterstock_2149968085.jpg?quality=75&w=500)
![Caretaker pushing older man in a wheelchair from behind](https://www.brookings.edu/wp-content/uploads/2024/07/shutterstock_2149968085.jpg?quality=75&w=500)
9:00 am EDT - 2:00 pm EDT
Past Event
9:00 am - 2:00 pm EDT
1775 Massachusetts Ave., NW
Washington, DC
The President’s Council of Advisors on Science and Technology’s (PCAST) 2012 report, Propelling Innovation in Drug Discovery, Development, and Evaluation recommended that U.S. Food and Drug Administration (FDA) develop a new regulatory pathway to accelerate the development and approval of drugs by allowing new treatments to be studied in a narrow subpopulation of high-risk patients with unmet therapeutic needs.
On August 1, 2013, the Engelberg Center for Health Care Reform (ECHCR) convened an expert workshop to discuss a proposed limited-use approval pathway for drugs developed in an expedited manner to meet unmet medical needs based upon the PCAST recommendation. This workshop is part of an ongoing cooperative agreement with the FDA, and brought together a diverse group of stakeholders, including clinicians, pharmacists, provider systems, health plans, industry representatives, and patients to discuss the potential benefits and implementation challenges of such a pathway. The conversation covered a variety of topics including:
9:15 am
9:30 am
10:30 am
12:45 pm
Vani Agarwal, Chloe Zilkha, Richard G. Frank
July 16, 2024
2024
Top of the Hill, Washington DC
10:00 am - 12:00 pm EDT
Quinn Sanderson
July 9, 2024