Blog

The Alliance’s blog offers a personal, inside look at our activities and perspectives on a range of timely issues. We encourage your feedback.

BACK TO BLOG

Author: Noel Lloyd

Date: December 22nd, 2015

The Alliance has been very active in ongoing activities surrounding the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA). As we head into the new year, here's an update on the latest.

The U.S. Food and Drug Administration (FDA) held two meetings in December with representatives from patient and consumer advocacy organizations to discuss progress in its negotiations with industry on the sixth reauthorization of the prescription drug user fee program and the fourth reauthorization of the medical device user fee program.

Vice President of Public Policy Cynthia Bens and Public Policy Assistant Ryne Carney represented the Alliance at both of these meetings.

In prepared remarks, Bens called for the expansion of existing mechanisms at FDA’s Center for Drug Evaluation and Research to encourage greater patient and caregiver input into endpoint development as part of PDUFA VI. Bens also focused on the need for additional staff at the Center for Devices and Radiological Health through MDUFA IV to evaluate patient-reported outcome data and other patient preference information.

These prepared remarks can be found here for PDUFA and here for MDUFA.






A Tribute to a Great Scientist

Author: Dan Perry

Date: March 11th, 2008

FDA Needs More Funding to Fulfill Its Mission

Author: Cynthia Bens

Date: March 18th, 2008

Spending or Investing? -- The Silver Book & Innovation

Author: Lindsay Clarke

Date: March 26th, 2008

Preventing the Flu: A Q & A with Dr. William Schaffner

Author: Noel Lloyd

Date: December 4th, 2017

A Recap of the Clinical Trials for Alzheimer’s Disease Conference

Author: Phyllis Greenberger

Date: December 1st, 2017

An Update on the Clinical Trials for Alzheimer’s Disease Conference

Author: Noel Lloyd

Date: November 7th, 2017

Living Longer & Loving It

Sign up for our electronic newsletter Living Longer & Loving It