Abstract
The unmet needs of many patients make the successful search for new and better drugs an urgent goal. Increasing regulatory demands have generated delays in the availability of new drugs and concerns about the long-term profitability of the innovative pharmaceutical industry. A rational and flexible approach to drug regulation could ease some of the most worrisome constraints without jeopardizing the public welfare. Changes in our national drug regulatory policy and in the performance of the Food and Drug Administration will serve our society better than drastic legislative mandates intended either to emasculate the FDA or to grant the agency broad new powers.
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