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GUIDANCE DOCUMENT

E7 Studies in Support of Special Populations: Geriatrics August 1994

Final

E7 Studies in Support of Special Populations: Geriatrics

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

It is important to ensure that clinical testing programs are carried out according  to harmonized
guidelines based on agreed ethical and scientific principles so  that the international development
of valuable innovative drugs is achieved with maximum efficiency. Harmonization in relation to
medicines for geriatric populations is an important issue because the total population of the
elderly will increase significantly in the coming years in Europe, Japan and the USA. The  use of
drugs in this population requires special consideration due to the frequent occurrence of
underlying diseases, concomitant drug therapy and the  consequent risk of drug interaction.
 


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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:

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Food and Drug Administration
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Rockville, MD 20852

All comments should be identified with the title of the guidance.