Category: FDA & Regulatory Policy (Page 4)

August 18, 2016

Alliance’s Bens Presents at August PDUFA VI Public Meeting

The Alliance’s Vice President of Public Policy Cynthia Bens was invited by the U.S. Food and Drug Administration (FDA) to speak on two panels at an August 15 public meeting focused on the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA).
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.
March 17, 2016

FY17 ACT-AD FDA Appropriations Request Letter

Letter to the House and Senate Appropriations Subcommittees on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies urging the Subcommittee to prioritize the U.S. Food and Drug Administration's (FDA) during Fiscal Year (FY) 2017 by increasing the agency's appropriated funding by $120 million. 
March 6, 2016

Senate HELP Combination Products Letter

Letter from the Alliance for Aging Research applauding the Senate Health, Education, Labor, and Pensions Committee's efforts in addressing the ways in  which combination products are reviewed by the U.S. Food and Drug Administration (FDA).     
February 18, 2016

The President’s Budget: Read the Numbers, Not the Headlines

The Obama administration’s FY 2017 vision for the federal government does not include continuing increases for America’s biomedical research community.
February 5, 2016

Cynthia Bens Named as President of the Alliance for a Stronger FDA Board of Directors

Cynthia Bens has been named as the president of the Alliance for a Stronger FDA Board of Directors.
December 22, 2015

A December Update on PDUFA and MDUFA

A December update on PDUFA and MDUFA
December 18, 2015

MDUFA Reauthorization Stakeholder Meeting Statement

This is a statement presented by Alliance Vice President of Public Policy Cynthia Bens at the December 18, 2015, stakeholder meeting regarding reauthorization of the Medical Device User Fee Act (MDUFA).
December 17, 2015

PDUFA Reauthorization Stakeholder Meeting Statement

This is a statement presented by Alliance Vice President of Public Policy Cynthia Bens at the December 17, 2015, stakeholder meeting regarding reauthorization of the Prescription Drug User Fee Act (PDUFA).