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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, 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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All written comments should be identified with this document's docket number: FDA-2020-D-1518.