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FDA Still Soliciting Applications For START Pilot As Deadline For Rare Disease Program Looms

 
• By Brenda Sandburg and Nielsen Hobbs

Agency anticipated receiving more applications for the program, which aims to bring Operation Warp Speed-like response to investigational rare disease therapies, than it has so far, though a last-minute ‘flood’ is still expected. CBER and CDER are accepting requests through 1 March.

Crossing finish line
FDA pilot program aims to get rare disease treatments across the finish line faster • Source: Shutterstock

The US Food and Drug Administration will soon be selecting sponsors to participate in its Support for clinical Trials Advancing Rare disease Therapeutics (START) pilot program, which is intended to speed up the development of novel drug and biological products to treat rare diseases, but competition for the slots may not be as intense as initially anticipated.

Sponsors can submit an amendment to their investigational new drug application requesting to participate in the program from 2 January to 1 March. The Center for Drug Evaluation and Research...

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