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

This workshop will bring together stakeholders from FDA, academia, and industry in a virtual setting to discuss the best practices for devel

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . FDA Announces a Workshop Entitled "Best Practices for Development and Application of Disease Progression Models"   The U.S. 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 16, 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.   Learn More and Register The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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