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 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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.