Center for Biosimilars

Evidence Gaps Continue to Shape Biosimilar Adoption in Pediatric Care

There are critical gaps in biosimilar adoption for pediatric patients, focusing on safety, regulatory challenges, and the ...
JD Supra

FDA announces public meeting on pediatric exclusivity and drug development

Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and ...
JD Supra

FDA Clarifies Approach to Pediatric Drug Development

On May 17, the U.S. Food & Drug Administration (“FDA”) issued two important draft guidance documents, which clarify the agency’s approach to requirements and incentives in the realm of pediatric drug ...
RAPS

EMA Revises Reflection Paper on Pediatric Extrapolation

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