For over 20 years, FDA has promoted the pursuit of increased information and the study of pharmaceutical products in pediatric patients. This initiative is a result of the dearth of data that existed for drug products that were and areoften administered to children. Under the Pediatric Research Equity Act (PREA), its re authorization, and the FDA Safety and Innovation Act (FDASIA), sponsors who are subject to PREA must now submit an initial Pediatric Study Plan (iPSP) early in the Investigational New Drug (IND)phase of development.
The purpose of the iPSP is to identify and plan for any necessary pediatric studies and assessments early on during development, even if the pediatric study is to be a postmarketing activity. Unless a drug has been granted orphan status, any pharmaceutical product considered anew active ingredient, or that has a new indication, new dosage form, new dosing regimen, or new route of administration must have an iPSP submitted by the sponsor.
FDA has specific requirements for iPSP submissions, and it is wise for sponsors to follow, as closely as possible, the Agency recommendations. Information included in a submission addresses, among other topics, overviews of the indication(s) and drug, plannedpediatric studies, waivers or deferrals for pediatric studies, planned non-clinical studies, and development timelines. The totality of the information provided to FDA is extremely important in the Agency’s decision-making process and mistake salong the way may result in costly development delays. Additionally, with the evolution of FDA opinions on clinical research and testing methods, possibilities exist for creative methods of data analysis and extrapolation so as to allow sponsors more efficient paths to satisfy PREA and iPSP requirements.
BRG can assist you with your PREA, iPSP, regulatory affairs and various other FDA compliance, submission, or response needs. Additionally, BRG regulatory experts have extensive experience designing and coordinating various FDA-required and sponsor-drivenstudies. These have included experimental (pivotal and non-pivotal clinical trials), observational, data-mining, and other pharmacovigilance and market vigilance assessments. Do not hesitate to contact us with questions regarding our IND consulting and NDA regulatory services, or a quote request.
BRG is a global scientific & regulatory consulting firm with extensive experience in the strategic development of drug products, biologics, medical devices, combination products and in FDA regulatory affairs. As such, BRG is an integral part of client decision-making processes.
The opinions and statements in this blog are those of the authors and do not necessarily reflect those of BRG. This blog is based on personal experience and reviews of information publicly available oridentified in other database searches.