Tuesday, November 20, 2018 8:44:38 AM
https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/significantamendmentstothefdcact/fdasia/ucm341027.htm
“21) What are the timelines for FDA to respond to a breakthrough therapy designation request?
FDA will respond to breakthrough therapy designation requests within 60 days of receipt of the request.”
All my comments are Rated As Pro.
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