Post-Notice of Compliance (NOC) Changes – Quality Guidance (English, HTML)

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Publisher-reported update

2021-07-07

This guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to Section C.08.004 of the Food and Drug Regulations. This may include pharmaceuticals, biologics and radiopharmaceuticals for human use and pharmaceutical, radiopharmaceutical and certain biotechnological products for veterinary use.

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