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Development of anti-infective drug products for the pediatric population
Development of anti-infective drug products for the pediatric population
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body. - Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, December 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Anti-Infective Agents
Drug Development
Pediatrics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration - Genre(s):
- Technical Report
- Abstract:
- The purpose of this guidance is to provide general recommendations on the development of antiinfective 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 vaccines. The general principles set forth in this guidance apply to drug and biological products. However, because of the complexity and limited experience with some biological products regulated by the Center for Biologics Evaluation and Research (CBER) (e.g., cellular and gene therapies, phage therapies), there may be additional development considerations. In such cases, CBER encourages sponsors to reach out to the applicable review division, as appropriate. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (7 pages)).
- NLM Unique ID:
- 9918351274906676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918351274906676