Impact of Drug Approval Pathways for Paediatric Inflammatory Bowel Disease

Volume: 16, Issue: 2, Pages: 331 - 335
Published: Aug 11, 2021
Abstract
Timely access to approved medications is a priority in paediatric inflammatory bowel disease [IBD]. To date, the timing of drug studies in paediatric IBD has been suboptimal, with most studies conducted long after approval has been granted for adult IBD. This delay in approval leads to extensive off-label prescribing of medications in children, often without clear guidance on optimal dosing. The European Medicines Agency [EMA] and U.S. Food and...
Paper Details
Title
Impact of Drug Approval Pathways for Paediatric Inflammatory Bowel Disease
Published Date
Aug 11, 2021
Volume
16
Issue
2
Pages
331 - 335
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