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GUIDANCE DOCUMENT

Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products Guidance for Industry and Food and Drug Administration Staff January 2011

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2010-D-0635
Issued by:
Guidance Issuing Office
Center for Tobacco Products

This guidance provides information for those submitting reports concerning substantial equivalence under section 905(j) of the FD&C Act, including FDA’s interpretation of the statutory sections related to substantial equivalence and recommendations on the form and content of section 905(j) reports.  

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2010-D-0635.

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