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Electronic Submission of Expedited Safety Reports From Investigational New Drug-Exempt Bioavailability/Bioequivalence Studies; Draft Guidance for Industry; Availability
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Zusammenfassung
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies." This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies through the FDA Adverse Event Reporting System (FAERS) database.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →