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Development of Anti-Infective Drug Products for the Pediatric Population Draft Guidance for Industry June 2020

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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

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 for the pediatric population.

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

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