Sponsors should begin early in development to understand how PREA affects them and plan how to incorporate its requirements into their development programs.
TORONTO (PRWEB) June 10, 2021
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 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.
Join Stacey Ayres, Vice President of Regulatory and Strategy, Camargo Pharmaceutical Services; Kumar Ilangovan, Medical Director, Paidion Research, Inc.; and Mihai Anghel, Manager of Oncology Solutions, Camargo Pharmaceutical Services, for the live webinar on Tuesday, June 29, 2021 at 1pm EDT (10am PDT).
For more information, or to register for this event, visit The Pediatric Research Equity Act (PREA) and Its Implications for Oncology Development.
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