FDA News: Issue 17-1, September 2022

Author: [AUTHOR] Published on 9/23/2022 6:00:00 AM

FDA Announces a Webinar on the FDA’s Recently Published Guidance on Bioavailability Studies

On Wednesday October 26, 2022, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) Small Business & Industry Assistance will host a webinar entitled, “An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs – General Considerations.” This webinar will provide additional clarity to an FDA final guidance for industry published on April 15, 2022 entitled, “Bioavailability Studies Submitted in NDAs or INDs – General Considerations,” which covers topics including, but not limited to, general bioavailability (BA) considerations, pre- and post-approval changes, in vitro and in silico approaches to BA, and alcohol considerations in relative BA.

The intended audience for this webinar includes regulatory scientists assessing BA studies as part of drug and biological product submissions, research coordinators overseeing in vivo studies in the context of drug and biological product submissions, drug development/new drug industry scientists involved with BA studies for new and existing drug and biological product dossiers, and foreign regulators. Continuing education credits are available for this webinar. See the website below for more details.

Workshop Objectives:
  • Discuss select case studies on various BA-related subtopics (e.g., pharmacodynamic endpoints, endogenous compounds, Narrow Therapeutic Index (NTI), biowaivers)
  • Conduct a Q&A panel to provide an opportunity for attendees to interact with subject matter experts
  • Date/Time of the Workshop:
    • Date: October 26, 2022
    • Time: 1:00 PM – 4:00 PM ET
    • This webinar is open to the public; however, registration is required and can be accessed HERE.
More information about this event can be found at: https://www.fda.gov/drugs/news-events-human-drugs/depth-look-final-fda-guidance-bioavailability-studies-submitted-ndas-or-inds-general-considerations

The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at https://public.govdelivery.com/accounts/USFDA/subscriber/topics and select Clinical Pharmacology Corner under Drugs.

We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.

This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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