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Regulatory IP:

Essentials of Lifecycle Management

The lifecycle management tools covered in this guide will help enhance value for biopharmaceutical investors, developers, and manufacturers and strengthen the incentives for continued medical progress.

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Gregory Glover | Blog

January 15, 2024

New FDA Draft Guidance Aims to Limit Pediatric Exclusivity Extension Awards

According to a recent Draft Guidance, FDA is considering eliminating written requests for pediatric exclusivity under the Best Pharmaceuticals for Children Act (BPCA) when the studies are already required under the Pediatric Research Equity Act (PREA). If finalized,... More

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