The Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry entitled “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.” The draft guidance is intended to assist those sponsors of new drug applications (NDAs), biologics license applications (BLAs) for therapeutic biologics, and supplements to such applications who are planning to conduct clinical studies in pediatric populations. Effectiveness, safety, or dose finding studies in pediatric patients involve gathering clinical pharmacology information, such as information regarding a product's pharmacokinetics and pharmacodynamics pertaining to dose selection and individualization. This draft guidance addresses general clinical pharmacology considerations for conducting studies so that the dosing and safety information for drugs and biologic products can be sufficiently characterized, leading to well-designed trials to evaluate effectiveness.
To ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 9, 2015. Details and a link to submit comments may be found here.