In-Depth Look at Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs

The FDA will host a meeting on 26 October 2022 to provide additional clarity to the final guidance with respect to Agency expectations for submissions containing Bioavailability information for drug products, and will discuss:

• Select case studies on various bioavailability (BA) related subtopics (e.g. pharmacodynamic (PD) endpoints, endogenous compound Narrow Therapeutic Index (NTI), biowaivers).
• Bioavailability Studies Submitted in NDAs and INDs – General Considerations
• Bioavailability Determination: Special Topics
• Relative Bioavailability Evaluation: Potential for Using Pharmacodynamic and Non-Traditional Pharmacokinetic Endpoints
• Recommended In Vitro Studies

The intended audience for this event is: Regulatory Scientists assessing bioavailability studies as part of IND/NDA/BLA submissions; Research Coordinators overseeing in vivo studies in the context of IND/NDA/BLA submissions; Drug Development/New Drug industry scientists involved with bioavailability studies for support of a new/existing IND/NDA/BLA dossier; and foreign regulators.

Please visit the FDA’s In-Depth Look at BA Final Guidance Meeting website to register.

FDA RESOURCES

Final Guidance for Industry: Bioavailability Studies Submitted in NDAs or INDs — General Considerations