Abstract
Merck Sharp & Dohme Research Laboratories has a corporate-approved administrative/scientific system in place for the development of product circulars and labeling pieces for all new Merck prescription products, and for the revision of all labeling pieces for marketed products. The core of this system is the Package Circular Review Committee (PCRC). The Charter of this Committee contains corporate directives for the on-going review of adverse reaction reports from Clinical Studies, Clinical Literature, Drug Experience Report Files, and animal studies and related literature. PCRC system, specific Charter directives, and adverse experience review system are presented in detail.
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