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GUIDANCE DOCUMENT

E7 Studies in Support of Special Populations: Geriatrics August 1994

Download the Final Guidance Document
Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics 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.
 

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.

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