Category: FDA & Regulatory Policy (Page 7)

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Statement on FDA Draft Guidance for Alzheimer’s Drug Development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.
November 14, 2011

FDA Under Fire

Last month, the FDA published a long awaited report on biomedical innovation, their only course of defense in the recent onslaught against the agency. Historically, the FDA has played a significant role in the protection of our health, assuming sole responsibility for the approval of medical products, but it appears that congressional confidence in the agency is waning.
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.  
June 8, 2011

Advocates: FDA deal with drug makers “opaque”

Consumer advocates are blasting the FDA for the process it has used to renegotiate the terms of the drug approval process following news that a deal has been reached with industry on proposed changes to the process.
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…