Guidance: Electronic Submission of Expedited Safety Reports from Investigational New Drug-Exempt Bioavailability/Bioequivalence Studies

TitleGuidance: Electronic Submission of Expedited Safety Reports from Investigational New Drug-Exempt Bioavailability/Bioequivalence Studies
ToC Doc Electronic Submission of Expedited Safety Reports from Investigational New Drug-Exempt Bioavailability/Bioequivalence Studies
Docket Number2022-16599
Type Notice
Subject Guidance:
Electronic Submission of Expedited Safety Reports from Investigational New Drug-Exempt Bioavailability/Bioequivalence Studies
Publication Date2022-08-03
Last Updated Date 2022-08-02 08:15:10 -0400
Last Public Inspection2022-08-02
Filed At2022-08-02T08:45:00.000-04:00
PDF 2022-16599_PI.pdf (107479 bytes)
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Number of Pages 5
Filing Typeregular
AgenciesFood and Drug Administration

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