CTD Section 1.12.15 Report
Summary
Section Name:
Request for waiver of in vivo bioavailability studies
Section Code:
1.12.15
Module Number:
1
Description:
Request to waive certain in vivo bioavailability and bioequivalence studies under certain conditions when the generic drug is identical to an approved drug and the dosage method renders the bioavailability/bioequivalence profiles self-evident
Submission Timing
Not applicable to gene therapies
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources