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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.

概要

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.

特集トピック

    • 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

参加対象

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

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