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Posted On: 10/16/2018 2:29:45 PM
Post# of 72446
A quote from FDA guidelines for BTD:
"Ideally, FDA should receive a breakthrough therapy designation request before initiation of the clinical trial(s) intended to serve as the primary basis for demonstration of efficacy if most of the benefits of designation are to be obtained."
I take this to mean ideally before end of phase 2 meeting.
And, there is no requirement for a meeting between FDA and applicant before FDA's decision about BTD. FDA's response to BTD request is either a designation or non-designation letter to applicant. In case of BTD being granted consequent meetings are scheduled separately.
See Process for Priority Review Designation on pages 30 - 33 in Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics
Link: https://www.fda.gov/downloads/Drugs/Guidances/UCM358301.pdf
"Ideally, FDA should receive a breakthrough therapy designation request before initiation of the clinical trial(s) intended to serve as the primary basis for demonstration of efficacy if most of the benefits of designation are to be obtained."
I take this to mean ideally before end of phase 2 meeting.
And, there is no requirement for a meeting between FDA and applicant before FDA's decision about BTD. FDA's response to BTD request is either a designation or non-designation letter to applicant. In case of BTD being granted consequent meetings are scheduled separately.
See Process for Priority Review Designation on pages 30 - 33 in Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics
Link: https://www.fda.gov/downloads/Drugs/Guidances/UCM358301.pdf
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