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비즈니스 · 2005. 1. 28.1 분 읽기
High Chemical Co. et al.; Proposal to Withdraw Approval of 13 New Drug Applications; Opportunity for a Hearing
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA) is announcing an opportunity for a hearing on the agency's proposal to withdraw approval of 13 new drug applications (NDAs) from multiple sponsors. The basis for the proposal is that the sponsors have repeatedly failed to file required annual reports for these applications.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →