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Development of Anti-Infective Drug Products for the Pediatric Population Guidance for Industry December 2021

Final Level 1 Guidance
Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The purpose of this guidance is to provide general recommendations on the development of anti-infective drug products, including antibacterial, antifungal, and antiparasitic products, for the pediatric population.

FDA encourages sponsors to discuss their initial pediatric study plans (iPSPs) for anti-infective drug products with the Agency early. In most instances, iPSPs must be submitted no later than 60 calendar days after the end-of-phase 2 meeting.

This guidance does not address the full scope of considerations for pediatric anti-infective drug product development. More detailed information on clinical pharmacology considerations for neonatal and pediatric studies (e.g., sample size, pharmacokinetic sampling, data analysis) is available in several guidances for industry. This guidance also does not apply to preventative...

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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:

Dockets Management
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-2020-D-1518.

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