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

Summary

The FDA has released a guidance for industry that finalizes recommendations for sponsors of INDs and applicants of NDAs, ANDAs, and supplements to request a waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms.