Rare Disease Endpoint Advancement Pilot Program

https://www.fda.gov/drugs/development-resources/rare-disease-endpoint-advancement-pilot-program?utm_medium=email&utm_source=govdelivery CBER and the Center for Drug Evaluation and Research (CDER) began accepting submissions to the Rare Disease Endpoint Advancement (RDEA) Pilot Program in September 2023. This innovative Pilot aims to accelerate rare disease drug development by fostering collaboration between sponsors and the FDA throughout the novel efficacy endpoint development process. The FDA welcomes RDEA submissions on a quarterly basis, with up to one eligible proposal selected per quarter. The deadline for submitting applications this quarter is June 31, 2024. For more information about the Program, visit Rare Disease Endpoint Advancement Pilot Program. Additionally, for guidance on submitting proposals to CBER, visit Submission Deadlines and Process | Rare Disease Endpoint Advancement Pilot Program. If you would like to connect with the FDA RDEA team, please email RDEA.Meetings@fda.hhs.gov. Submission Deadlines and Process | Rare Disease Endpoint Advancement Pilot Program https://www.fda.gov/drugs/development-resources/submission-deadlines-and-process-rare-disease-endpoint-advancement-pilot-program?utm_medium=email&utm_source=govdelivery