Documents connected to "Food and Drug Administration"

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 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.
August 15, 2016

Comments on CMS-3295-P by the Alliance

The Alliance for Aging Research submitted comments to the Centers for Medicare and Medicaid Services (CMS) on its proposal rule: CMS-3295-P, Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care.
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).     
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).
October 29, 2015

Dr. Califf Nomination Support Letter

The Alliance for Aging Research signed on to a letter supporting the nomination of Dr. Robert Califf as Commissioner of the Food and Drug Administration (FDA). 
May 18, 2015

Letter to DeGette and Upton on 21st Century Cures Bill

This letter is from the Alliance to Rep. Fred Upton and Rep. Diana DeGette applauding their work around the 21st Century Cures bill.
May 15, 2015

ACT-AD Letter to DeGette and Upton Re: 21st Century Cures

This letter is from the ACT-AD Coalition to Rep. Fred Upton and Rep. Diana DeGette applauding their work around the 21st Century Cures bill.
April 20, 2015

Letter to Various Representatives Regarding Fiscal Year (FY) 2016 302(b) Allocation for the Labor, HHS, Education, and Related Agencies Appropriations Subcommittee

This letter from various organizations, including the Alliance for Aging Research, to Rep. Harold Rogers, Rep. Tom Cole, Rep. Nita Lowey, and Rep. Rosa DeLauro requests "to restore the Fiscal Year (FY) 2016 302(b) allocation for the Labor, HHS, Education and Related Agencies Appropriations Subcommittee to at least the FY 2010 level of $163.6 billion." 
January 30, 2015

Letter to Hatch and Bennet in Support of the Promise for Antibiotics and Therapeutics for Health (PATH) Act

This letter was from various organizations, including the Alliance for Aging Research, to Sen. Orrin Hatch and Sen. Michael Bennet to "express support for S. 185, the Promise for Antibiotics and Therapeutics for Health (PATH) Act, legislation to establish a new limited population antibacterial drug approval pathway for antibiotics to treat serious or life-threatening infections for which there exists an unmet medical need."
December 15, 2014

Exploring Scientific Evaluation and Intake Recommendations of Bioactive Compounds and the Public/Private Path to Get There – Meeting Summary

On October 23, 2014, the Alliance for Aging Research, with support from Mars, Inc., convened key stakeholders from the Institute of Medicine (IOM) and other non-profit organizations, the U.S. and Canadian Governments, academia, and private industry to discuss scientific evaluation of bioactive compounds. Dr. Joanne Lupton, Distinguished Professor of Nutrition at Texas A&M University, co-chaired the meeting with Susan Peschin, President and CEO of the Alliance for Aging Research, and described the goals of the meeting as follows: (1) to identify concrete ideas for creating an evaluation process for bioactives, including intake recommendations, and (2) to address issues with and opportunities for public-private partnerships. She also shared a working definition of bioactive compounds and suggested it be used for the discussion: Bioactives, according to the working definition, are “constituents in foods or dietary supplements, other than those needed to meet basic human needs, which are responsible for changes in health status.” The meeting included four presentations that helped frame the discussion. These presentations were on perspectives from the Subcommittee on Dietary Reference Intakes (DRIs), application of the DRI paradigm to bioactives, lessons learned from research on cocoa flavanols, and development of public-private partnerships. Download the full meeting summary to learn more.
September 4, 2014

Tips for Grandparents on Safe Medicine Storage

As part of a collaboration with the CHPA Educational Foundation, the Alliance is helping spread the word about safe medicine…
April 1, 2010

Alliance President Makes Remarks at a Hearing on Prescription Drug User Fee Act Reauthorization

On April 12th, Alliance President & CEO Daniel Perry presented remarks at a public meeting on the reauthorization process for…