Zdrowie i gospodarka · 11.05.2005
International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development; Availability; Reopening of Comment Period
The Food and Drug Administration (FDA) is reopening until June 11, 2005, the comment period for the notice, published in the Federal Register of February 9, 2005 (70 FR 6888). In the notice, FDA announced the availability of a draft guidance entitled "Q8 Pharmaceutical Development." FDA is reopening the comment period to provide additional time for public comment consistent with the time for comment provided by other ICH regulatory entities.