FDA Releases Draft Guidance on Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms

Summary

The FDA is releasing a draft guidance that outlines recommendations for sponsors of new drugs to waive in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms, based on a biopharmaceutics classification system. This guidance aims to provide clarity for companies seeking to expedite the development process.