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A correction has been published: N Engl J Med 2006;355(25):2712.

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Volume 355:618-623 August 10, 2006 Number 6
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A Proposal for Radical Changes in the Drug-Approval Process
Alastair J.J. Wood, M.D.

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Drug development is the process by which new therapies are created and brought to market to treat diseases. It is hard to imagine that such an activity would not be universally admired and lauded, but recently the pharmaceutical companies that develop new drugs have been criticized by patients, legislators, and the press.1 This criticism has been focused on the high cost of prescription drugs and the disparity between the costs of these drugs in the United States and in other developed countries such as Canada and the United Kingdom.1 In addition to concern about cost, a more recent issue is . . . [Full Text of this Article]

Lack of Long-Term Safety Data

Unmet Phase 4 Commitments

Lack of Clinically Meaningful End Points

Inadequate Incentives for Drug Development with High Commercial Risk

Incentives for the Development of Drugs for High-Need, High-Risk Areas

Incentives for Drugs That Are "First in Class"

Conclusions


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From the Vanderbilt University School of Medicine, Nashville.


Related Letters:

A New Approach to Drug Development
Guda H. E., Mayer D., Brown S., Frangioni J. V., Wood A. J.J.
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N Engl J Med 2006; 355:2045-2046, Nov 9, 2006. Correspondence

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