Category: FDA & Regulatory Policy (Page 7)

February 10, 2015

21st Century Cures Feedback Letter

The Alliance for Aging Research submitted a feedback letter on the 21st Century Cures discussion draft released on January 27, 2015 to Chairman Upton and Ranking Member DeGette.
February 10, 2015

ACT-AD 21st Century Cures Letter

Accelerate Cure/Treatments for Alzheimer’s Disease (ACT-AD) submitted a letter the House Committee on Energy and Commerce to provide feedback on the 21st Century Cures discussion draft released on January 27, 2015.    
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.
August 29, 2014

Don’t Just Act Out, Act to Increase Representation in Clinical Trials

Vice President of Public Policy Cynthia Bens talks about clinical trials.
August 26, 2014

Let This Be a Lesson for Change

Alliance President and CEO Susan Peschin, MHS, on mental health in older adults
May 22, 2014

Turning a Blind Eye on Patients

Alliance Vice President of Public Policy Cynthia Bens discusses AMD and older adults. 
February 7, 2013

Statement on FDA Draft Guidance for Alzheimer’s Drug Development

Accelerate Cure/Treatments for Alzheimer’s Disease (ACT-AD) coalition released a statement in response to guidance from the U.S. Food and Drug Administration (FDA) on the development of drugs for Alzheimer’s Disease.
January 6, 2012

Are we there yet?

Many of you may still have this phrase ringing in your ears if you traveled with children for any length of time this past holiday season. Representatives from the ACT-AD Coalition, chaired by the Alliance for Aging Research, heard these same words almost two years ago, not uttered from the mouths of babes, but rather by prominent officials at the Food and Drug Administration (FDA) in a conversation regarding evidence to support the use of biomarkers for Alzheimer’s disease in clinical trials for “disease-modifying” therapies.
January 4, 2012

Use Biomarkers in Alzheimer’s Disease Clinical Trials

Use biomarkers in Alzheimer's disease clinical trials, says expert group.