Electronic Submission of Expedited Safety Reports From Investigational New Drug-Exempt Bioavailability/Bioequivalence Studies; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies."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.