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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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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:
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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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter 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.