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Electronic Format for Registration and Listing
Law
CFR 21
Food and Drugs
Food and Drug Administration, Department of Health and Human Services
Drugs: General
Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code
Electronic Format for Registration and Listing
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Section
207.61
How is registration and listing information provided to FDA?
Section
207.65
How can a waiver of the electronic submission requirement be obtained?