Monograph Reform

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CHPA comments on proposed recommendations for the reauthorization of the Prescription Drug User Fee Act.

Oct 31, 2011

The objective of this guideline is to define the minimum stability data package to support the commercial distribution of OTC monograph drug products in the United States per climatic zone.

Learn about CHPA's current slate of federal legislative priorities including OTC regulatory reform, dietary supplement regulation modernization, supply chain and product integrity, and more.

Explore consultants who can assist with communications, regulatory policy, strategy, operations, compliance, product development, and more.

Learn about the OTC review process, drug monographs, and time and extent applications.

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