On Thursday, October 28, the Alliance submitted a comment on the performance goals and procedures in the Prescription Drug User Fee Act (PDUFA) VII commitment letter. PDUFA authorizes the FDA to collect fees from companies that produce specific drug and biological products to support the drug review process. PDUFA has decreased the times to review new drugs, improved engagement between the FDA and patient stakeholders, increased the patient-centricity of the agency, and has accelerated the pace at which new treatments are brought to market. It was first passed in 1992, and it is reauthorized every five years. PDUFA is up for renewal in 2022.
The letter addresses staff hiring and retention, enhancing older adult clinical trial representation and real-world evidence, patient-focused drug development, and digital health technologies/decentralized trials. You can read the letter here.
About the Alliance for Aging Research
The Alliance for Aging Research is the leading nonprofit organization dedicated to accelerating the pace of scientific discoveries and their application to vastly improve the universal human experience of aging and health. The Alliance believes advances in research help people live longer, happier, more productive lives and reduce healthcare costs over the long term. For more than 30 years, the Alliance has guided efforts to substantially increase funding and focus for aging at the National Institutes of Health and Food and Drug Administration; built influential coalitions to guide groundbreaking regulatory improvements for age-related diseases; and created award-winning, high-impact educational materials to improve the health and well-being of older adults and their family caregivers. For more information, visit www.agingresearch.org