2022-19410: General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products," replacing the December 2014 draft guidance of the same name. This draft guidance, once finalized, will assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license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 pediatric populations. In addition, this draft guidance, once finalized, will assist investigators in the design and planning of, and Institutional Review Boards in the assessment of, clinical studies in pediatric populations.
The agency’s own summary, as published.
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