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GUIDANCE DOCUMENT - Canada

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The Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) should be consulted to determine the extent of data generation which is necessary to support NDSs, ANDSs or S(A)NDSs. The Post-Notice of Compliance (NOC) Changes: Quality Document should be consulted for drug products ...

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