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Breakthrough In Two Pages: FDA Offers Preliminary Advice

 
• By Derrick Gingery

Agency now allows sponsors of potential breakthrough therapies to request preliminary advice, but sponsors may not necessarily want to use it.

FDA now offers preliminary advice on whether a product in development could warrant a breakthrough designation, another seemingly lesser-known attempt at limiting the burden of reviewing formal requests to be part of the program.

Sponsors considering applying for a breakthrough designation request now can ask for "preliminary breakthrough therapy designation request advice."

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