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.
Darren Scheer, MPH, RAC is Vice President of Epidemiology and Pharmacovigilance for BRG. He has more than 20 years of experience with FDA regulated products, including drugs,biologicals, devices, combination products, and tissue. He has directed and developed various pharmacovigilance and epidemiological assessments. These include a wide variety of regulatory and development projects requiring FAERS/MAUDE analyses, health claims database assessments, adverse event/safety summaries, and product labeling adequacy.
Mikel Alberdi, MPH, RAC is Vice President of Regulatory Affairs for BRG. Hehas over a decade of regulatory affairs experience, with expertise infacilitating FDA meetings and the pivotal submissions (e.g. pre-IND, IND, NDA,505(b)(2), ANDA, and post marketing supplements). He oversees all BRGdevelopment activities and ensures regulatory appropriateness of the information provided by BRG.
Dr.Catherine E. Patterson is Chief Scientific Officer for BRG and offers regulatory expertise utilizing her background in Molecular Biology with academic experience in life science research, grant writing and publishing. She actively directs and participates in regulatory submissions, clinical trials and safety surveillance activities on behalf of BRG clients.
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.