All 46 of the novel drugs approved by the Center for Drug Evaluation and Research last year were within the timelines dictated by user fee agreements, 15 were the first in their class, 36 were approved in the US before they were approved abroad, and 28 were approved through an expedited process, according to a CDER report. New cancer therapies, antibiotics, orphan drugs, and therapies for patients with multiple sclerosis, Parkinson's disease and amyotrophic lateral sclerosis were among those approved, writes CDER Director Janet Woodcock.
CDER approved 15 first-in-class drugs last year
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