Join Mayer Brown FDA regulatory partner George O’Brien and associate Jessica Lehrman for the next installment of our FDA Lifecycle Management webinar series. This month, George and Jessica will discuss the role of pediatric studies in product development, with an emphasis on the studies conducted under the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA).
George and Jessica will cover topics including:
- Complying with required pediatric assessments under PREA
- Obtaining appropriate waivers and deferrals under PREA
- Proposed Pediatric Study Requests and Written Requests under the BPCA
- Maximizing your chances for obtaining pediatric exclusivity under the BPCA
- Understanding the application of the six-month pediatric exclusivity extension
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