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MANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH MAP 5015.5, Rev. 1 OFFICE OF PHARMACEUTICAL SCIENCE CMC Reviews of Type III DMS for Packaging Materials CONTENTS PURPOSE BACKGROUND

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What is cmc reviews of type?

The cmc reviews of type are evaluations of chemistry, manufacturing, and controls (CMC) data for investigational or approved drugs.

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Pharmaceutical companies and regulatory authorities are required to file cmc reviews of type.

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CMC reviews of type are typically filled out by experts in the field of pharmaceutical manufacturing and regulation.

What is the purpose of cmc reviews of type?

The purpose of cmc reviews of type is to ensure the safety, efficacy, and quality of drugs through the evaluation of CMC information.

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CMC reviews of type must report detailed information on the drug's composition, manufacturing process, and quality control measures.

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