Zdrowie i gospodarka · 11/28/1994

International Harmonization; Draft Policy on Standards; Availability

The Food and Drug Administration (FDA) is publishing a draft policy on its development and use of standards with respect to international harmonization of regulatory requirements and guidelines. Specifically, the draft policy is intended to address the conditions under which FDA participates with standards bodies outside of FDA, domestic or international, in the development of standards applicable to products regulated by FDA. The policy also covers the conditions under which FDA uses the resultant standards, or other available domestic or international standards, in fulfilling its statutory mandates for safeguarding the public health.