1 May 2025

💊FDA Comment Request on Tropical Disease Priority Review Vouchers

Agency Information Collection Activities; Proposed Collection; Comment Request; Tropical Disease Priority Review Vouchers

Summary

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Tropical Disease Priority Review Vouchers.

Agencies

  • Health and Human Services Department
  • Food and Drug Administration

Business Impact ?

$$ - Med

The notice discusses the proposed collection of information regarding Tropical Disease Priority Review Vouchers, impacting pharmaceutical companies by emphasizing compliance with regulatory requirements, which can affect their research and development strategies. The program incentivizes drug development for tropical diseases, potentially leading to financial benefits through priority review applications.

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