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# Pediatric Anti-Infective Drug Product Guidance
- URL: https://www.fdaweb.com/pediatric-anti-infective-drug-product-guidance/
- Published: 2021-12-09T12:00:00.000Z
- Updated: 2026-09-14T17:25:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150739

FDA has published a guidance, *Development of Anti-Infective Drug Products for the Pediatric Population*, with general recommendations on the development of antibacterial, antifungal, and antiparasitic products for the pediatric population. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-anti-infective-drug-products-pediatric-population?ref=fdaweb.com) says the agency encourages sponsors to discuss their initial pediatric study plans for anti-infective products with FDA staff early.

The guidance does not address the full scope of considerations for pediatric anti-infective drug product development. It also does not apply to preventive vaccines.