# Pediatric Drug Development:  Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/pediatric-drug-development-regulatory-considerations-complying-with-the-pediatric-research-equity-act-and-qualifying-for-pediatric-exclusivity-under-the-best-pharmaceuticals-for-children-act/c7de020f-03c0-4902-a320-07443487355d

> FDA guidance document: Pediatric Drug Development:  Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act. Issue date: May 17, 2023. Get complete insights and analysis.

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## Details

- Title: Pediatric Drug Development:  Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2023-05-17
- Comment Close Date: 2023-07-17
- Last Changed: 2024-04-11
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2005-D-0460">FDA-2005-D-0460</a>

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