- Docket Number:
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Guidance Issuing OfficeCenter 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.
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:
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.