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GUIDANCE DOCUMENT

Qualified Infectious Disease Product Designation Questions and Answers Guidance for Industy May 2021

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2017-D-7001
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides information to sponsors about FDA’s implementation of Title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA), titled Generating Antibiotic Incentives Now (GAIN). The GAIN provisions create incentives for the development of antibacterial and antifungal drug products that treat serious or life-threatening infections. The purpose of this guidance is to provide sponsors a resource for information on FDA’s policies and procedures related to the designation of a qualified infectious disease product (QIDP) under GAIN.

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All written comments should be identified with this document's docket number: FDA-2017-D-7001.

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