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The Pediatric Research Equity Act (PREA) and Its Implications for Oncology Development

Date: June 29, 2021

Stacey Ayres, PhD, Camargo
Kumar Ilangovan MD, MSPH, MMCi, FAAP, FACP, Paidion
Mihai Anghel BSc, MBA, Cert. in Law, Camargo

The Pediatric Research Equity Act (PREA) of 2003 gives the FDA the authority to require pediatric studies in certain development programs, with the goal of obtaining pediatric labeling for more products and thereby expanding access to new medicines for children. It was amended by the FDA Reauthorization Act (FDARA) of 2017, in ways that have had a far-reaching impact on oncology drug developers.

An oncology product’s molecular target, rather than its indication, is now the key in determining whether a program requires pediatric studies, so sponsors anticipating that PREA requirements will be deferred or waived entirely may be surprised when the FDA requires pediatric trials before accepting a marketing application. Therefore, sponsors should begin early in development to understand how PREA affects them and plan how to incorporate its requirements into their development programs.

Join this webinar with the experts from Camargo Pharmaceutical Services and Paidion Research to explore whether PREA requirements apply to your program, how compliance can expand the market potential for your product, and how PREA and FDARA are helping to address unmet needs for pediatric oncology patients.

Key Takeaways:

  • The background and purpose of PREA and how FDARA has amended the requirements for oncology programs
  • How sponsors can determine whether they will need to conduct pediatric studies and at which stage of development they should begin considering PREA
  • The continued impact of PREA and FDARA on the oncology development landscape
  • How complying with PREA and adding a pediatric indication for a product can expand its market potential

Download the Webinar