1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter C - DRUGS: GENERAL
  5. Part 207 - 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
  6. Subpart D - Listing
  7. 21 CFR § 207.55
21 CFR § 207.55
What additional drug listing information may FDA require?
June 25, 2020
CFR

For a particular listed drug, upon our request, the registrant must briefly state the basis for its belief that the drug is not subject to section 505 or 512 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act.

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§ 207.54 What listing information must a registrant submit for a drug that it salvages?
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§ 207.57 What information must registrants submit when updating listing information and when?

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