Qualified Infectious Disease Product Designation Questions and Answers Guidance for Industy May 2021
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-D-7001.