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GUIDANCE DOCUMENT

Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees Guidance for Industry January 2005

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2001-D-0134
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance describes FDA’s current thinking on what will be considered a separate marketing application and what will constitute clinical data for purposes of the user fee provisions of the Federal Food, Drug, and Cosmetic Act (Act).

 FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

Submit Comments

Submit Comments Online

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-2001-D-0134.

 
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