1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
  5. Part 516 - NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
  6. Subpart B - Designation of a Minor Use or Minor Species New Animal Drug
  7. 21 CFR § 516.23
21 CFR § 516.23
Timing of requests for MUMS-drug designation
June 25, 2020
CFR

A sponsor may request MUMS-drug designation at any time in the drug development process prior to the submission of an application for either conditional approval or approval of the MUMS drug for which designation is being requested.

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§ 516.22 Permanent-resident U.S. agent for foreign sponsor
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§ 516.24 Granting MUMS-drug designation

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