Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter D - Drugs for Human Use |
Part 314 - Applications for FDA Approval to Market a New Drug |
Subpart E - Hearing Procedures for New Drugs |
§ 314.201 - Procedure for hearings.
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§ 314.201 Procedure for hearings.
Parts 10 through 16 apply to hearings relating to new drugs under section 505 (d) and (e) of the act.