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Posted On: 12/28/2021 5:20:55 PM
Post# of 148925
It's on the FDA.gov website and it looks like a rule to me.
What are the timelines for FDA to respond to a breakthrough therapy designation request?
Sixty days from Nov. 5 is Jan. 4. We will hear by then.
What are the timelines for FDA to respond to a breakthrough therapy designation request?
Quote:
FDA will respond to breakthrough therapy designation requests within 60 days of receipt of the request.
Sixty days from Nov. 5 is Jan. 4. We will hear by then.
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