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Home » SIX NDA APPROVALS REQUIRE COMMITTEE REVIEW IN 2003
SIX NDA APPROVALS REQUIRE COMMITTEE REVIEW IN 2003
January 28, 2004
The Center for Drug Evaluation and Research (CDER) approved 72 new drug applications (NDAs) during calendar year 2003, but less than 10 percent of those required convening an advisory panel meeting to mediate problems between the agency and the sponsor about data presented or other controversial issues.