Substantial Equivalence Reports

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Tobacco Products
  6. Exemption Requests and Substantial Equivalence Reports
  7. Substantial Equivalence Reports

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Section
1107.16

Submission of a substantial equivalence report.

Section
1107.18

Required content and format of an SE Report.

Section
1107.19

Comparison information.

Section
1107.20

Amendments.

Section
1107.22

Withdrawal by applicant.

Section
1107.24

Change in ownership of an SE Report.