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General clinical pharmacology considerations for neonatal studies for drugs and biological products
General clinical pharmacology considerations for neonatal studies for drugs and biological products
- Collection:
- Health Policy and Services Research
- 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, July 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biological Products
Clinical Studies as Topic
Drug Development
Government Regulation
Infant Health
Pharmacology, Clinical
United States
United States. Food and Drug Administration - Genre(s):
- Guideline
Technical Report - Abstract:
- This guidance is intended to assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and supplements to such applications who are planning to conduct clinical studies in neonatal populations. This guidance provides recommendations for neonatal clinical pharmacology studies, whether the studies are conducted pursuant to section 505A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), section 505B of the FD&C Act,7 or neither. Effectiveness, safety, or dose-finding studies in neonates involve assessing clinical pharmacology information, such as information regarding a product’s pharmacokinetics (PK) and pharmacodynamics (PD) to inform dose selection and individualization. As such, the general considerations described in this guidance apply to any neonatal studies which incorporate clinical pharmacology assessments. This guidance does not discuss the timing to initiate neonatal studies. Questions regarding the appropriate timing for the initiation of neonatal studies should be discussed with the relevant FDA review division. 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 (i, 20 pages))
- NLM Unique ID:
- 9918486678506676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918486678506676