FDA Issues Final Guidance on BA Studies in INDs and NDAs

Today, the FDA published the final guidance titled “Bioavailability Studies Submitted in NDAs or INDs — General Considerations” (here).  The final guidance comes after the FDA incorporated comments that it received on the draft of the same name issued on February 26, 2019.  That 2019 draft guidance replaced the March 2014 guidance titled “Bioavailability and Bioequivalence Studies […]

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