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FDANonrulemakingFDA-2005-D-0460

Guidance for industry on Pediatric Drug Development Under the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act

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Last modified
Jan 8, 2026
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closed 1207d ago
American Academy of Pediatrics (AAP) filings
2

Activity

American Academy of Pediatrics (AAP) filed 2 comments on this docket between Jul 21, 2023 and Jul 21, 2023. 2 other organizations filed here. The comment window closed 1207d ago.

What American Academy of Pediatrics (AAP) filed (2)

Jul 21, 2023· Comment from American Academy of Pediatrics· FDA-2005-D-0460-0023

Filed on regulations.gov — full text not in the inline record.

Jul 21, 2023· Comment from American Academy of Pediatrics· FDA-2005-D-0460-0022

Filed on regulations.gov — full text not in the inline record.

Abstract

Docket Status: OPEN

View on regulations.gov →
Guidance for industry on Pediatric Drug Development Under the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act (FDA) — American Academy of Pediatrics (AAP) | OpenPolis