JNDA definition

JNDA means a new drug application filed with the MHLW required for marketing approval for the applicable Product in Japan.
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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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JNDA means a Japanese new drug application and any other applicable submission to the PMDA for pharmaceutical, biologic, or device approval.
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Examples of JNDA in a sentence

  • USAFA cadets participating in this exchange have a large selection of JNDA courses from which to choose.

  • Corporate income tax is paid on dividends is levied on profit distributed as dividends to the shareholders that are individuals or non-residents of Georgia at the rate of 15/85 of net distribution.

  • Also in March, the Japanese New Drug Application (JNDA) was submitted to the Ministry of Health, Labour and Welfare seeking marketing approval for osilodrostat.

  • GGT Crescent Cool Springs TN Venture, LLC c/o GGT Cool Springs Holdings, LLC CNL Center at City Commons 000 Xxxxx Xxxxxx Xxxxxx Xxxxxxx, XX 00000 Attention: Xxxxxxxx X.

  • The potential future milestone payments include up to $20.0 million upon first JNDA submissions in the Otsuka Territory, up to $70.0 million upon the first NHI Price Listing for NEXLETOL in the Otsuka Territory, and up to $50.0 million upon the achievement of the primary major adverse cardiovascular events (“MACE”) in the CLEAR Outcomes study and the CV risk reduction rate on the U.S. label, depending on the range of relative risk reduction in the CLEAR Outcomes study.


More Definitions of JNDA

JNDA means (i) the single application or set of applications for approval and/or pre-market approval to Manufacture and Commercialize in the Territory a pharmaceutical or biologic product filed with the MHLW, and any related registrations with or notifications to the MHLW, and (ii) all supplements and amendments that may be filed with respect to any of the foregoing.
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JNDA means the Japanese equivalent of an NDA.
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JNDA means a Japanese new drug application, or an amendment thereof filed with the MHLW through PMDA under Article 14 of the Pharmaceuticals and Medical Devices Act of Japan (Law No. 145 of 1960, as amended).
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JNDA means an application for Regulatory Approval of a Licensed Product in the Otsuka Territory.
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JNDA has the meaning set forth in Section 3.1(i).
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JNDA means a New Drug Application filed with the Koseisho required for marketing approval for the applicable Product in Japan.
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JNDA means a Japanese New Drug Application, which is filed with the MHLW in order to gain the MHLW's approval to Commercialize a pharmaceutical product in Japan for the indications set forth in the Japanese New Drug Application.
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