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GUIDANCE DOCUMENT

M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries September 2005

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2005-D-0459
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

It is desirable for regulators and pharmaceutical industry to engage in an intensive information exchange during the drug development phase, the drug evaluation and approval phase and the post-authorization phase. The standardization of medicinal product information is regarded as one of the key elements of this information flow.


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-2005-D-0459.

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