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Sample formats for Form FDA 356h_2011 February 2011

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

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

Attachment II Sample Formats—

Form FDA 356h


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


Sodium Fluoride F 18 Injection

Submit Comments

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-2000-D-1542.

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