GUIDANCE DOCUMENT
Development of Anti-Infective Drug Products for the Pediatric Population Draft Guidance for Industry June 2020
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2020-D-1518
- Issued by:
-
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.
Submit Comments
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.