Summary: Guidance Document- Post-Notice of Compliance (NOC) Changes: Safety and Efficacy
Date adopted: 2009/09/02
Date posted: 2020/03/23
Effective date: 2020/04/01
The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs (i.e., changes to a drug that have received a NOC pursuant to section C.08.004 of the Food and Drug Regulations).
Who this guide is for
Sponsors of pharmaceuticals, biologics, and radiopharmaceutical drugs for human use.
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C1
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