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Title 21 - Food and Drugs
Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Subchapter A - GENERAL
Part 99 - DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
21 CFR Subpart C
21 CFR Subpart C
Manufacturer's Submissions, Requests, and Applications
June 25, 2020
§
99.201
Manufacturer's submission to the agency
§
99.203
Request to extend the time for completing planned studies
§
99.205
Application for exemption from the requirement to file a supplemental application
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