동향
동향 내용
Number of New Drug Applications (NDAs) and Biologics License Applications (BLAs) submitted
분류 New Drug 조회 2383
발행년도 2014 등록일 2015-07-27
출처 FDA (바로가기)
 Marketing Applications (New Drug Applications (NDAs) and Biologics License Applications (BLAs)) are applications to legally market a product in the U.S. for a specific use; these applications have legislatively mandated timelines for review.

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리스트 이전글과 다음글
이전글이전글 CPG Sec. 440.100 Marketed New Drugs Without Approved NDAs and ANDAs
다음글다음글 Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies