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

  • Also in March, the Japanese New Drug Application (JNDA) was submitted to the Ministry of Health, Labour and Welfare seeking marketing approval for osilodrostat.The active substance of Isturisa® is osilodrostat, a cortisol synthesis inhibitor.

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

  • This deed may be varied with the consent of a simple majority of those voting at a duly convened meeting of the PATROLAJC.

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

  • One formal interim data analyses to support the Japanese New Drug Application (JNDA) submission will be completed.


More Definitions of JNDA

JNDA means a new drug application filed with the Koseisho required for marketing approval for the applicable Licensed Product in Japan.
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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. [See License Agreement Section 1.68]
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JNDA means (a) the single application or set of applications for approval and/or pre-market approval to manufacture and commercialize in Japan a biologic or pharmaceutical or product filed with the MHLW, and any related registrations with or notifications to the MHLW, and (b) all supplements and amendments that may be filed with respect to any of the foregoing.
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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 filed with the PMDA for approval to market and sell a Product in Japan.
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JNDA has the meaning set forth in Section 3.1(i).
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JNDA means an NDA submitted to Regulatory Authority in Japan.
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