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Re: FDA response by Dale Severance
Last week I attended a luncheon briefing by officals of the FDA. They were presenting the goals and accomplishiments of the agency to secure continuing legislation. About two or three years ago legislation was adopted to permit the FDA to charge a fee when and application for drug approval was submitted for their consideration . The agency was require to set goals and reach thaose goals to continue receiving these special fees. The jist of the presentation was that applications have increased 300% in the last three years and approval time has been cut in half. It is my understanding from conversations with some parties that FDA approval is held up currently over the content of the statements on the packageing and Upjohn can not commercially release the drug till the packaging is approved.Dale dales99846@xxxxxxx
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