1998 Final Rule - Waivers

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Table of Contents

1998 Final Rule - Waivers

1998 Final Rule

Pediatric Rule Waivers

Full and Partial Waivers

Criteria for Full Waivers

Criteria for Partial Waivers

Meaningful Therapeutic Benefit

Preamble List

Preamble List

PPT Slide

Process for Waiver

Process for Waiver

External Review

Items for Committee Discussion

Author: Florence Houn