Landscape of Post-Marketing Requirements Under the Pediatric Research Equity Act for Antibiotics from 2009–2024

Landscape of Post-Marketing Requirements Under the Pediatric Research Equity Act for Antibiotics from 2009–2024

<b>Background/Objectives:</b> We reviewed Post-Marketing Requirements (PMRs) under the Pediatric Research Equity Act (PREA) for antibiotics approved in adults from 2009 to 2024 to better understand factors associated with PMR study completion. <b>Methods</b>: Initial PMRs, in...

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Bibliographic Details
Main Authors: Daniel Selig, Funmi Aminu, Sue Cammarata, Ting Chen, Lauren Dolak, Stephen Duprez, Stephanie Ecker, Lisa Gault, Sandra George, Margaret Harkins, Clayton Litchmore, Michael Serenko, William Waverczak, Doug Girgenti
Format: Article
Language:English
Published: MDPI AG 2025-06-01
Series:Antibiotics
Subjects:
anti-bacterial agents
antibiotics
clinical trials
drug development
infectious disease medicine
pediatrics
Online Access:https://www.mdpi.com/2079-6382/14/6/583
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