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New Critical Path Report Highlights Research Needed to Foster,Generic Drug Development

will be withdrawn from the market after 2008. The new report will help ensure FDA has an adequate scientific basis to review inhaler applications that use an alternative, hydrofluoroalkane.

The report also calls for research on new bioequivalence methods tailor-made for each challenging drug class. These include lung function tests and molecular level imaging for inhalation drugs; particle size distribution tests for nasal sprays; and methods for direct measurement of drug delivered to the skin.

In addition, the report highlights possible research projects that might lead to new modeling and simulation tools for drug absorption, drug release and other drug development issues and to alternative methods for seeking waivers from clinical bioequivalence studies.

Last year FDA issued the Critical Path Opportunities Report listing 76 specific scientific projects that, if undertaken, would help modernize the Critical Path sciences. This companion document focuses more narrowly on the scientific challenges unique to the development of generic drugs.

To learn more about the Critical Path Initiative consult:
www.fda.gov/oc/initiatives/criticalpath/

Information on FDA's Generic Drug Office is available at:
www.fda.gov/cder/ogd/index.htm.

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Media Inquiries:
Karen Riley, 301-827-6242
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