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비즈니스 · 2007. 6. 28.1 분 읽기
Menley & James Laboratories, Inc. et al.; Proposal to Withdraw Approval of Six New Drug Applications; Opportunity for a Hearing
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA) is announcing an opportunity to request a hearing on the agency's proposal to withdraw approval of six 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 →