Category: User Fees

July 12, 2017

Five Questions (and Answers) about the FDA Reauthorization Act of 2017

Right now, the U.S. Congress is considering the FDA Reauthorization Act of 2017 , legislation that will reauthorize the pharmaceutical, medical device, generic drug, and biosimilar user fee agreements. The five-year deal is one of the most important health care bills Congress will vote on this year.
April 3, 2017

Alliance’s Bens Will Testify on MDUFA and PDUFA Reauthorization

On April 4, the Alliance for Aging Research’s Vice President of Public Policy Cynthia Bens will testify before the U.S. Senate Committee on Health, Education, Labor and Pensions about the reauthorization of the Prescription Drug User Fee Act and the Medical Device User Fee Act. You can watch the hearing here.
March 28, 2017

Alliance’s Bens Offers Testimony on MDUFA before House Committee

Today, the Alliance for Aging Research's Vice President of Public Policy Cynthia Bens testifed before the U.S. House of Representatives' Energy and Commerce Committee, Subcommittee on Health, in regard to reauthorization of the Medical Device User Fee Act (MDUFA).
March 27, 2017

Testimony before Energy and Commerce Committee, Subcommittee on Health, on Examining FDA’s Medical Device User Fee Program

On March 28, Alliance for Aging Research Vice President of Public Policy Cynthia Bens testified before the United States House of Representatives' Energy and Commerce Committee, Subcommittee on Health, at its hearing on the FDA’s Medical Device User Fee Program.
August 30, 2016

Alliance Comments on the FDA’s Commitment Letter for PDUFA VI

In response to a call from the U.S. Food and Drug Administration (FDA) for feedback on its proposed Commitment Letter for the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA), the Alliance for Aging Research submitted comments to the FDA for consideration.
August 23, 2016

Alliance Comments on PDUFA VI Commitment Letter

The Alliance provided comments in response to the U.S. Food and Drug Administration's PDUFA VI Commitment Letter.
June 15, 2016

Alliance Offers Comments on FDA OTC Monograph User Fees

Last Friday, on June 10, Vice President of Public Policy Cynthia Bens presented comments on behalf of the Alliance at a U.S. Food and Drug Administration public meeting focused on OTC monograph user fees. 
June 10, 2016

OTC Monograph User Fee Public Meeting Remarks

These are remarks made by Alliance Vice President of Public Policy Cynthia Bens at the U.S. Food and Drug Administration's public meeting on OTC Monograph User Fees on June 10, 2016.
December 22, 2015

A December Update on PDUFA and MDUFA

A December update on PDUFA and MDUFA
June 30, 2011

PDUFA V Can Help Patients and the FDA

On June 26, 2011 I was interviewed by BioCentury This Week to share the Alliance for Aging Research’s impressions on the fifth reauthorization of the Food and Drug Administration’s Prescription Drug User Fee program. Thanks to Congress, we and other active patient groups were able to lend an early voice in helping to shape how user fees might be used to help speed the delivery of better treatments and cures to patient in need of relief from Alzheimer’s, Cancer, Parkinson’s and many more diseases.