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CDER manufacturing supplement median time to approval is 5.4 months in fiscal 1996 -- report to industry.

Executive Summary

FDA DRUG MANUFACTURING SUPPLEMENT APPROVALS JUMPED 39% IN FY 1996 over fiscal 1995 (ended Sept. 31), the Center for Drug Evaluation & Research indicates in a report on the 1996 NDA review process prepared for the regulated industry. CDER approved 1,422 manufacturing supplements in fiscal 1996, compared to 1,024 in the preceding 12 months. The median total time to approval for manufacturing supplements in fiscal 1996 was 5.4 months, down from 5.8 months in fiscal 1995 and 7.7 months in fiscal 1994.
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