What has the CDER done to improve service to the public?
A. For a long time, people lauded the quality of the CDER drug review process, but criticized it for being too slow. The FDA began to address the issue in 1993 with the establishment of user fees. Since the industry is receiving a service from the government through CDER’s review of its marketing applications, many felt industry should contribute directly toward the costs of the review process. Congress, industry, and the FDA negotiated the user fee program. Industry pays fees to add to the FDA’s resources for reviewing new drug applications. In exchange, the FDA makes a commitment to meet certain goals for review times. The CDER has been meeting all those goals. In fact, it has exceeded almost all of the goals, and it expects to continue to exceed them. Basically, the review times have been cut in half. The program has been so successful that it has been renewed for two more five-year terms. The approval process has been further improved by CDER’s accelerated approval procedure. Under
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