Japan NDA definition

Japan NDA or “JNDA” means the Japanese equivalent of an NDA filed with the Koseisho (i.e., the Japanese Ministry of Health and Welfare, or any successor agency thereto).
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Japan NDA or “JNDA” means the Japanese equivalent of an NDA filed with the Koseisho (i.e., the Japanese Ministry of Health and Welfare, or any successor agency thereto). “[***]” has the meaning set forth in [***].
Sample 1

Examples of Japan NDA in a sentence

  • He attended the Command ment of National Defense Studies in the and General Staff Course and Advanced School of Defense Sciences at the National General Staff Course at the JGSDF Staff Defense Academy of Japan (NDA).

  • Up until three years ago, I had been serving as the President of the National Defense Academy of Japan (NDA) for five years and eight months.

  • Our partner Astellas has filed its NDA for roxadustat for the treatment of anemia in dialysis patients with the PMDA, and the Phase 3 results used to support the Japan NDA are described in the section below captioned “Roxadustat for the Treatment of Anemia in Chronic Kidney Disease in Japan.

Related to Japan NDA

  • ANDA means an abbreviated new drug application filed with the FDA, pursuant to its rules and regulations (or any equivalent or replacement mechanism).

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.

  • EU GDPR means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC.

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • Health Canada means the section of the Canadian Government known as Health Canada and includes, among other departments, the Therapeutic Products Directorate and the Health Products and Food Branch Inspectorate;

  • Distillery manufacturing license means a license issued in accordance with

  • FDA means the United States Food and Drug Administration.

  • MHLW means the Japanese Ministry of Health, Labour and Welfare, and any successor agency thereto.

  • Licensed Territory means worldwide.