fda-guidances

FDA quietly kicks off process that could inform future rare disease regulatory reforms

Reforms buried within the FY2023 omnibus spending bill require the development of a new report looking at the regulatory processes of the U.S. and E.U. as they relate to the development of drugs for rare diseases, and to offer recommendations on how to improve those processes in the U.S. Today, the FDA unveiled a contract notice that explains the process for how it will develop that report, obtain public input, and deliver the report’s final recommendations.

Background: legislative efforts to bolster rare disease drug development

Defining a “rare disease:” In the U.S., a disease or condition is defined as rare by the Orphan Drug Act (ODA) if it affects fewer than 200,000 people.

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