Breakthrough In Two Pages: FDA Offers Preliminary Advice
This article was originally published in The Pink Sheet Daily
Agency now allows sponsors of potential breakthrough therapies to request preliminary advice, but sponsors may not necessarily want to use it.
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Agency staff discuss how they offer early development advice to sponsors before a breakthrough decision is made and reassure them if the status is denied.
User fees won't support dedicated staff, but rather FTEs that will work on the popular program as needed.
Office of New Drugs Director recommends that EMA be careful how its sets the bar for its similar PRIME program to ensure it remains meaningful.