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November 10, 2005

Non-nano policy: Shortening approval cycle for vaccines

The Wall Street Journal discusses plans by the FDA to expedite vaccine approval. Expedited approval processes and enhancing the overall speed and efficiency of validating the safety and effectiveness of new drugs and technology would be useful and critical in accelerate the adoption of new technology like molecular manufacturing with medical applications.

The FDA would quickly work to approve any generic versions of Roche Holding AG's antiviral Tamiflu. Roche has said it would set up licensing arrangements with other companies to produce Tamiflu as part of an effort to boost the supply of the drug, which governments are stockpiling in the event of a flu pandemic.

Dr. von Eschenbach, who took over the FDA about six weeks ago, said by working with the NIH -- which is helping to test the Sanofi bird-flu vaccine -- and companies in the beginning of the process that a vaccine or drug would then be able to be approved in about six to eight weeks once a formal approval application is submitted, rather than a more typical 10-month review period. He said by working with a company during the vaccine and drug development process that the FDA would be able to advise companies on the manufacturing and testing processes.

Dr. von Eschenbach, who also heads the National Cancer Institute, a unit of the NIH, said there are efforts under way at the NIH to develop new vaccines and flu treatments. Typically, the FDA doesn't get significantly involved in the drug development process and waits for companies to submit applications to approve a new drug or vaccine. The agency will advise a company in setting up proper clinical studies and other technical aspects before an application is submitted if requested by the company.

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