NDA/MAA definition

NDA/MAA means a New Drug Application / Marketing Authorization Application / Biologics License Application submitted and filed with a Regulatory Authority in a country or group of countries in the Territory necessary for approval of a Product for commercial sale in such country or group of countries in conformance with Applicable Laws.
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NDA/MAA means an NDA together with the marketing authorization application simultaneously submitted to the EMEA.
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NDA/MAA means, with respect to a Licensed Product, a filing serving to apply for Marketing Authorization including (i) in the United States, a New Drug Application (as [***] Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Confidential treatment has been requested with respect to this information. defined in the FDC Act and the regulations promulgated thereunder (21 CFR 314)), (ii) in the European Union, a Marketing Authorization Application (MAA), or (iii) in any other jurisdiction, a comparable filing, and, in each case, any amendments and supplements thereto.
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Examples of NDA/MAA in a sentence

  • Sankyo will be responsible for filing, and shall own, regulatory filings such as the IND or NDA/MAA.

  • The Phase III Clinical Trial milestone and NDA/MAA approval milestones for each Additional Liquidia Respiratory Product shall be paid at (i) one hundred percent (100%) for the first to third Additional Liquidia Respiratory Products reaching this Milestone Event; (ii) 50% for the fourth to sixth Additional Liquidia Respiratory Products reaching this Milestones Event.

  • Such Loxo-Bayer Supply Agreements shall address the forecasting, ordering and delivery of Licensed Products and provide, inter alia, representations from Loxo that Licensed Products supplied thereunder have been Manufactured in accordance with Laws (including cGMP), the applicable specifications, the requirements set forth in the applicable IND/CTA, NDA/MAA and/or Marketing Authorization, and shall contain such other terms as are reasonably and customary for agreements of such type.


More Definitions of NDA/MAA

NDA/MAA means (i) a New Drug Application in the United States for authorization to market a Company Product or [*], as applicable, as provided in the Applicable Laws and filed with the FDA; or (ii) an application for Regulatory Approval to market a Company Product or [*], as
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