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Quality Takes Time, FDA’s CDER Reminds Drug Makers

Lessening the workload is proving to diminish waste

Michael Causey
Wed, 02/04/2015 - 12:21
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Scholars still debate how long it took to build the Great Wall of China, but it’s generally agreed it was built in stages between the 5th century B.C. and the 16th century A.D. The Great Pyramid of Giza took about 20 years to construct, according to ancient historians, but it must be remembered that Egypt’s rulers were pretty rough on their nonvolunteer workforce. Deadlines had a deeper meaning back then.

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By contrast, the Center for Drug Evaluation and Research (CDER) Quality Initiative has been with us some 10 years or about the time it took the United States to finish constructing the Panama Canal. Both projects have had to dig through—and around—a lot of muck. At the peak of work, excavators in Panama carved out the equivalent of the English Channel Tunnel every 14 weeks. It’s not fair to hold the agency to that same standard.

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