FDA Launches START Pilot Program to Help Accelerate Development of Rare Disease Therapies

FDA | CDER | Small Business and Industry AssistanceINDUSTRY NEWS . FDA Launches START Pilot Program to Help Accelerate Development of Rare Disease TherapiesFDA is taking steps to help further accelerate the development of novel drug and biological products for rare diseases. Today, the agency is announcing the opportunity for a limited number of development programs to participate in the Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program. Selected participants of the START Pilot Program will receive Read more…

FDA CDER launched the Accelerating Rare disease Cures (ARC) Program

In May 2022, FDA CDER launched the Accelerating Rare disease Cures (ARC) Program to bridge the gapbetween the complexities of rare disease drug development and the pressing needs of patients withrare diseases to have treatment options. The ARC Program has emerged as a conduit for empoweringrare disease stakeholders (including patients, patient advocates, drug developers, researchers, andfederal partners) to harness their collective experiences and expertise to drive progress. One notableinitiative launched is the Learning and Education Read more…