Drugs

2 Pediatric Drug Approval Guidances

FDA has published two draft guidances that when finalized will provide recommendations to support the approval of pediatric drugs, biological products, and vaccines under the Pediatric Research Equity Act (PREA) and/or the Best Pharmaceuticals for Children Act (BPCA). The two documents revise and replace a previous draft guidance.

The first of the new guidances, Pediatric Drug Development: Regulatory Considerations—Complying with the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act, is intended to assist in the development of drug products to comply with the pediatric study requirements under PREA and to describe the process for qualifying for pediatric exclusivity and the protections that exclusivity offers under the BPCA. The document’s contents cover an Introduction, Overview of Regulatory Strategy for Pediatric Drug Development, Pediatric Research Equity Act, Best Pharmaceuticals for Children Act, Elements Common to PREA and the BPCA, Additional Information, and a Glossary.

The second guidance, Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations, is intended to assist the industry in developing data and obtaining information needed to support the approval of drug products in pediatric populations. The document addresses selected clinical, scientific, and ethical issues regarding the development of drugs for pediatric use when such drugs are subject to PREA and/or the BPCA. The guidance does not address the clinical development of drugs that are not subject to either of the laws. Its contents cover an Introduction, Background, Legislative and Regulatory Context, and Scientific Considerations for Pediatric Drug Development.

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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