Breakthrough In Two Pages: FDA Offers Preliminary Advice

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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