Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only)

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. These new drugs may include pharmaceuticals, biologics, and radiopharmaceuticals for human use, including those submissions for which a NOC has been recommended but issuance of the NOC has been placed on hold.