Drugs

Pharmacology Pediatric Studies Guidance

FDA has published a draft guidance, General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products, to assist sponsors of INDs, Section 505 NDAs, BLAs, and supplements to those applications who are planning to conduct clinical studies in pediatric populations. The document also is intended to assist clinical investigators in the design and planning of, and Institutional Review Boards in the assessment of, clinical studies in pediatric populations.

“The guidance addresses general clinical pharmacology considerations for conducting studies so that the dosing and safety information for drugs in pediatric populations can be sufficiently characterized, leading to well-designed trials to evaluate effectiveness,” the guidance says.

It does not describe (1) the standards for the approval of drugs in the pediatric population; (2) the determination that the course of a disease is the same in adults and pediatric populations; or (3) the clinical pharmacology studies for the development of vaccine therapies, blood products, or other products not regulated by CDER.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome