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There is a Federal Register Notice to inform you that FDA wants stakeholders like you—patient and consumer advocacy group members, health care professionals, and scientific and academic experts—to participate in monthly phone meetings to reauthorize PDUFA.
We want to encourage you to participate in an important opportunity to provide input to FDA and ensure that diverse perspectives are included in the discussions. FDA needs your response by August 28th.
The Prescription Drug User Fee Act (PDUFA) is set to expire in September 2017. This law authorized FDA to collect user fees from regulated industry for the process of reviewing human drugs. User fees fund and help speed certain activities within the new drug approval process. In order to ensure that the renewal takes into account a broad range of health care provider, patient, and consumer voices, it is critical to have organizations representing diverse communities participate.
PDUFA has been renewed five times. FDA began the most recent reauthorization process on July 15, 2015 by holding a public meeting for people to discuss their opinions about reauthorizing PDUFA. In order to renew the law again, the law* requires that FDA:
(1) Consult with a range of stakeholders to develop recommendations for the law, and
(2) Hold monthly discussions with patient and consumer advocacy groups to balance patient and consumer needs with negotiations between FDA and regulated industry.
This is an important opportunity for you to make your voice heard about the practices that guide FDA. Stakeholders who identify themselves through this notice will be included in all stakeholder consultations while FDA negotiates with industry.
How to Join:
To join these stakeholder consultation meetings, please designate one or more representatives from your organization who will commit to participating in monthly phone meetings and preparing for the discussions. If a stakeholder decides to participate in these meetings at a later time, they may join the remaining monthly stakeholder consultation meetings after notifying FDA.
If you intend to participate in PDUFA reauthorization stakeholder meetings, please email PDUFAReauthorization@fda.hhs.
gov by August 28, 2015.
Your email should include you or your group representative’s name, title, affiliation, address, email address, phone number, and any special accommodations required because of disability.
Meetings are expected to begin in September or October 2015. Once FDA receives your email, you or your representative will receive confirmation and additional information about the first meeting. If you have any questions you may contact Cariny Nuñez, Public Health Advisor at email@example.com
*Section 736B(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h-2(d)
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