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# Anti-Infective Pediatric Drug Development Guidance
- URL: https://www.fdaweb.com/anti-infective-pediatric-drug-development-guidance/
- Published: 2020-07-06T12:00:00.000Z
- Updated: 2026-09-14T16:20:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147114

FDA has published a draft guidance, *Development of Anti-Infective Drug Products for the Pediatric Population*, with general recommendations on developing anti-infective drug products for the pediatric population. The [document](https://www.fda.gov/media/139586/download?ref=fdaweb.com) does not address the full scope of considerations for pediatric anti-infective drug development. Additional information is available through several other guidances, the agency says.

FDA says it encourages sponsors to discuss their initial pediatric study plans for anti-infective drug products with the agency early and, in most instances, no later than 60 calendar days after an end-of-Phase 2 meeting.