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DIA Direct: Advancing the Development of Orphan Advanced Therapy Products

Explore FDA programs and policies driving innovation in rare disease treatments in a dynamic session led by the Office of Orphan Products Development and CBER.

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Overview

Join DIA's Advanced Therapies Community for this upcoming webinar.

The US Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) will facilitate a discussion on the topic of FDA programs and relevant policies available to support and advance the development and evaluation of new treatments for rare diseases.

Featured topics

    • Orphan Product Designation
    • Orphan Drug Exclusivity Program
    • Rare Pediatric Disease Priority Review Voucher Program (RPD PRV)
    • Expedited Program for Serious Conditions
    • Accelerated Approval of Drugs and Biologics

Who should attend?

The webinar is designed for professionals in regulatory affairs and the pharmaceutical industry.

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