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Electronic Format for Registration and Listing

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Drugs: General
  6. 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
  7. 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?

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