FDA News: Issue 32, October 2021

Author: [AUTHOR] Published on 10/8/2021 5:00:00 AM

FDA Announces a Workshop Entitled “Best Practices for Development and Application of Disease Progression Models”

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research will host a virtual public workshop entitled “Best Practices for Development and Application of Disease Progression Models” on November 19, 2021. This workshop will bring together stakeholders from FDA, academia, and industry in a virtual setting 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.  

Key topics of discussion include:
  • Role of disease models in drug development and regulatory review
  • Lessons learned from past experiences of applying disease models in drug development
  • Best practice considerations for disease modeling to support drug development and regulatory decisions
  • Best practice considerations for clinical trial simulations based on disease progression/natural history models to support drug development and regulatory decisions.
The date, time, and location of the workshop are as follows:

Date: November 19, 2021
Time: 9:30 am - 2:30 pm
Location: This is a virtual public workshop

This workshop fulfills FDA’s performance commitment under the Prescription Drug User Fee Act (PDUFA) VI, in accordance with section I of PDUFA VI Performance Goals, “Ensuring the Effectiveness of the Human Drug Review, part J, Enhancing Regulatory Decision Tools to Support Drug Development and Review.”

For more information on and to register for this workshop, please visit https://go.usa.gov/xMxPZ. Registration will close on November 9, 2021. You may view the announcement of this workshop in the Federal Register at https://www.regulations.gov (Docket No. FDA-2021-N-0031).

If you have any additional questions about this workshop, please contact Maryanne Dingman at OCPWorkshops@fda.hhs.gov.

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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