Posts connected to "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 20, 2017

Update on Patient-Focused Drug Development Meeting on Sarcopenia

On April 6, the U.S. Food and Drug Administration held a public meeting on Patient-Focused Drug Development (PFDD) for sarcopenia. The focus of the meeting was to obtain patient perspectives on “symptoms and the daily impacts of their condition, current approaches to treatment, and decision factors taken into account when selecting a treatment.”
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.
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.
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. 
March 29, 2016

Alliance’s Bens to Participate in Symposium on Frailty

On April 7, the Alliance's Vice President of Public Policy Cynthia Bens will participate in a symposium titled "Frailty as a Baseline Stratification Parameter and Potential Therapeutic Target" at the 28th Annual EuroMeeting in Hamburg, Germany.
December 22, 2015

A December Update on PDUFA and MDUFA

A December update on PDUFA and MDUFA
November 12, 2015

Participate in an Alzheimer’s Disease Clinical Trial

Participating in Alzheimer's disease clinical trials is a valuable way you and your loved ones can personally impact this disease.
August 3, 2015

Two New Clinical Studies Request Volunteers

We are sharing the following information about two new clinical studies.
July 16, 2015

Cynthia Bens Comments from MDUFA and PDUFA Meetings

Alliance Vice President of Public Policy Cynthia Bens took part in two important meetings at the U.S. Food and Drug Administration this week.
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.