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Support Regulatory Change to Boost Wisconsins Biotech Sector

Wisconsins business leaders in biotechnology and genetic testing know well the importance of federal regulations on analyte-specific reagents (ASRs), essentially the active ingredients of many genetic tests. Recent efforts to reform to these regulations could provide exciting opportunities for Wisconsin companies.

Under current regulations, manufactures of ASRs, unlike traditional medica......

Full article >>> new diagnostic tests to market, and the promise of their technology remains unfulfilled.

Regulatory change is in the air. Wisconsin biotech companies should monitor the FDAs actions closely over the coming months. Several dominant players in the in vitro diagnostics industry have proposed to the FDA a draft Guidance Document that would create a new category of in vitro analytical tests......

Full article >>> esentatives, Steven Gutman, M.D. (director of the FDAs Office of In Vitro Diagnostics) indicated that the Agency is revisiting the ASR regulations, but is not prepared yet to issue any new guidance or new rules. It appears unlikely that the IVAT proposal will be applied as broadly as its proponents have hoped. One of the Agencys primary concerns, it appears, is that the IVAT proposal ma......

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'"/> By Gabriel S. Gross 11/09/03

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