Criteria for Partial Waivers

• No meaningful therapeutic benefit over existing treatment and not likely to be used in a substantial number of pediatric patients in the specified age group(s)
• Studies are impossible or highly impractical to conduct in the specified age group(s)
• Evidence the product would be unsafe or ineffective in the specified age group(s)
• Reasonable efforts to develop a formulation (if one is needed) have failed

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