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Breakthrough Therapy Designation Request (EPSC Section VI) - CBER
Expedited Programs for Serious Conditions-Drugs and Biologics
0765_Agency Guidance
Breakthrough Therapy Designation Request (EPSC Section VI) - CBER
OMB: 0910-0765
OMB.report
HHS/FDA
OMB 0910-0765
ICR 202309-0910-011
IC 263124
Breakthrough Therapy Designation Request (EPSC Section VI) - CBER
( )
⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0910-0765 can be found here:
2024-08-23 - Revision of a currently approved collection
2024-07-22 - Extension without change of a currently approved collection
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