FDA News: Issue 7-1 March 2023

Author: [AUTHOR] Published on 3/17/2023 6:00:00 AM

FDA Announces a Public Webinar on Statistical Approaches to Establishing Bioequivalence

On March 14, 2023, the US Food and Drug Administration’s (FDA’s) Small Business and Industry Assistance (SBIA) will hold a two-hour webinar entitled "A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence."

In December 2022, FDA issued a draft guidance for industry entitled Statistical Approaches to Establishing Bioequivalence, which provides recommendations to sponsors and applicants who intend to use equivalence criteria in analyzing in vivo or in vitro bioequivalence (BE) studies for investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications. This guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches generally and in specific situations. When finalized, this guidance will replace the February 2001 FDA guidance for industry “Statistical Approaches to Establishing Bioequivalence” and will represent FDA’s current thinking on this topic. This webinar will take a deeper look into the draft guidance for new and revised content and provide clarification to comments received through the public docket.

In this webinar, FDA will discuss:
  • In vitro bioequivalence assessment
  • Statistical methods for narrow therapeutic index and highly variable drug products
  • Comparative clinical endpoint bioequivalence studies
  • Studies in multiple groups
  • Bioequivalence statistics for adhesion and irritation studies
  • Dose scale for bioequivalence assessment
Date/Time of the Webinar:
Date: March 14, 2023
Time: 10:00 AM – 12:00 PM ET

This webinar is open to the public; however, registration is required by clicking here.

This workshop is intended for generic and new drug industry, including current and potential applicants who are interested in submitting an application for a generic drug or a new drug, regulatory reviewers for generic and new drug development and assessments, researchers working on generic drugs and new drugs, consultants focused on bioequivalence, clinical research coordinators, healthcare professionals specializing in prescribing and dispensing medications, and foreign regulators.

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 or click the button below 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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