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Regulations last checked for updates: May 14, 2025
Title 21 - Food and Drugs last revised: May 12, 2025
All Titles
Title 21
Chapter I
Part 1107
Subpart C - Subpart C—Substantial Equivalence Reports
§ 1107.16 - Submission of a substantial equivalence report.
§ 1107.18 - Required content and format of an SE Report.
§ 1107.19 - Comparison information.
§ 1107.20 - Amendments.
§ 1107.22 - Withdrawal by applicant.
§ 1107.24 - Change in ownership of an SE Report.
authority:
21 U.S.C. 371
,
374
,
387e
,
387i
,
387j
; Pub. L. 117-103, 136 Stat. 49
source:
76 FR 38974, July 5, 2011, unless otherwise noted.
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