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GUIDANCE DOCUMENT

Sample formats for Form FDA 356h_2011 February 2011

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Attachment II Sample Formats—

Form FDA 356h

for

Ammonia N 13 Injection Fludeoxyglucose F 18 Injection (FDG F 18)

and

Sodium Fluoride F 18 Injection


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.