FDA News: Issue 5, March 2021

Author: [AUTHOR] Published on 3/2/2021 8:03:00 AM

FDA Announces Availability of a Federal Register Notice to Solicit Public Comments to Inform a Public Workshop on Best Practices for the Development and Application of Disease Progression Models

On February 24, 2021, the US Food and Drug Administration (FDA) announced the availability of a Federal Register notice titled “Best Practices for Development and Application of Disease Progression Models; Public Workshop; Establishment of a Public Docket; Request for Comments.” This notice opens a docket to solicit public input on topic areas for an upcoming workshop on modeling disease progression.

One of the goals of the Prescription Drug User Fee Act of 2017 (PDUFA VI), part of the Food and Drug Administration Reauthorization Act of 2017 (FDARA), is advancing model-informed drug development (MIDD). A workshop to be held in 2021, entitled "Best Practices for Development and Application of Disease Progression Models," will fulfill FDA’s performance commitment under PDUFA VI. The purpose of this public workshop is to discuss the best practices for developing disease progression models and their application to support drug development decisions; share experiences and case studies that highlight the opportunities and limitations in the development and application of disease progression models including models for natural history of disease and clinical trial simulations; and discuss the knowledge gaps and research needed to advance the development and use of disease progression models.

The FDA is requesting comments from the public to help identify areas of interest to be discussed during the workshop, given the wide range of approaches to data collection, aggregation modeling, model development, verification and validation, and potential applications in drug development and regulatory review. The outcome will help the Agency inform the public on current experiences, emerging techniques, and opportunities to streamline drug model development and facilitate decision-making processes.

The “Best Practices for Development and Application of Disease Progression Models; Public Workshop; Establishment of a Public Docket; Request for Comments” Federal Register Notice is available at https://www.federalregister.gov. Please refer to this notice for more details. You may submit your comments regarding the notice to the docket (Docket No. FDA-2021-N-0031) available at https://www.regulations.gov up to 30 days following publication in the FEDERAL REGISTER. Your comments do make a difference and can impact the outcomes of FDA regulatory policy. Share your knowledge and experience and make your voice count.

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 http://go.fda.gov/subscriptionmanagement (note: this link does not work with Internet Explorer) 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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