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BioPharmaceutical North America United States

Pediatric Written Requests Maintain Societal Value of BPCA Exclusivity, AAP Argues

This article was originally published in The Pink Sheet Daily

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Executive Summary

Response to Merz citizen petition from American Academy of Pediatrics tells FDA that Congress didn’t intend for pediatric-only products to automatically gain exclusivity bonus.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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