Events

The Alliance and our partner organizations host various events to raise awareness about the field of aging research and to present the latest innovations and advancements that are helping extend people’s healthspans. Those events are featured here.

BACK TO EVENTS

Start Date: September 20th, 2016

Start Time: 5:00PM

End Time: 6:30PM

City: Washington, DC

Contact Address: 1400 Pennsylvania Ave. NW

Contact Name: Samantha Hunter

Phone: 202.293.2856

Email: [email protected]

Progress Toward Reauthorization of the Prescription Drug and Medical Device User Fee Programs to Benefit Older Adults

Overview

Every five years, the U.S. Food and Drug Administration (FDA) must seek reauthorization of its user fee programs. The core purpose of user fees is to fund direct review activities for drugs, medical devices, generic and biosimilar products. User fees enable the FDA to maintain appropriate staffing levels and processes across centers to ensure the timely evaluation of medical products. The reauthorization process begins with direct negations between the FDA and representatives from regulated industry. FDA meets in parallel with the patient and consumer stakeholders to seek additional input. 

The current PDUFA V and MDUFA III programs will expire in September of 2017. FDA began negotiations with industry and consultation with the stakeholder community in September of 2015. The Alliance for Aging Research (Alliance) has been the only patient stakeholder from the aging community consistently advocating before the FDA for enhancements to the user fee programs that would improve the development of treatments and medical devices intended for use by people 65 and older. Major areas of focus for the PDUFA VI and MDUFA IV discussions include: administrative improvements to strengthen the agency’s workforce; enhancing initiatives that support integration of patient perspectives into medical product development and review; increasing transparency of benefit/risk determinations; increasing efficiency and predictability in pre-market approval pathways; and exploring the use of post-market data in regulatory decision-making. 

Convened by the Alliance, this expert roundtable will provide an opportunity for leaders from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) to reflect on progress that has been made to reauthorize the prescription drug and medical device user fee programs in advance of the 2017 deadline. Speakers will also share their thoughts on what PDUFA VI and MDUFA IV mean for the future of FDA’s workforce, key initiatives to promote regulatory science, and any specific impacts the reauthorization may have on innovations for older adult patients.
 

Moderator

Susan Peschin, MHS
President and CEO
Alliance for Aging Research

 

Panel Speakers

Dr. Janet Woodcock, MD
Director, Center for Drug Evaluation and Research
U.S. Food and Drug Administration

Dr. Jeff Shuren, MD, JD
Director, Center for Devices and Radiological Health
U.S. Food and Drug Administration

Janet Jenkins-Showalter
Head, US Regulatory Policy
Genentech

Andrew Emmett
Senior Director, FDA Liaison Office
Pfizer


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