Marketing Approval Application definition
Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.
Marketing Approval Application or “MAA” means a filing for marketing approval (not including pricing or reimbursement approval) in a country other than the United States, in each case with respect to a Licensed Product in the Territory.
Marketing Approval Application or “MAA” means an application for a Marketing Approval;
Examples of Marketing Approval Application in a sentence
Apollomics shall draft and submit to the JSC the initial Commercialization Plan for discussion and approval at least [***] prior to the anticipated submission to a Regulatory Authority of the Marketing Approval Application of each Licensed Product in the Licensed Territory.
More Definitions of Marketing Approval Application
Marketing Approval Application means a marketing authorization application (including or comparable to an NDA), including all supporting documentation and data submitted for such application to be accepted for review or approval, filed with the requisite REGULATORY AUTHORITY of any country of the TERRITORY, and requesting approval for commercialization of PRODUCT for a particular indication in such country.
Marketing Approval Application means the appropriate application or registration submitted to the appropriate Regulatory Authority in the Territory to seek Regulatory Approval.
Marketing Approval Application or “MAA” means an NDA, an sNDA, a BLA or an sBLA.
Marketing Approval Application means a BLA, NDA, MAA or similar application for Regulatory Approval that is filed with the applicable Regulatory Authority(ies) in any country or jurisdiction.
Marketing Approval Application or “MAA” shall mean a New Drug Application (as defined in Title 21 of the U.S. Code of Federal Regulations, Section 314.50, et. seq.), or a comparable filing for Marketing Approval (not including pricing or reimbursement approval) in a country, in each case with respect to a Product in the Territory.
Marketing Approval Application or “MAA” means BLA, sBLA, NDA, sNDA in the United States or any equivalent thereof in any other country or jurisdiction in the world. As used herein: “BLA” means a Biologics License Application and amendments thereto filed pursuant to the requirements of the FDA, as defined in 21 C.F.R. § 600 et seq., for FDA approval of a Licensed Product and “sBLA” means a supplemental BLA; and “NDA” means a New Drug Application and amendments thereto filed pursuant to the requirements of the FDA, as defined in 21 C.F.R. § 314 et seq., for FDA approval of a Licensed Product and “sNDA” means a supplemental NDA.
Marketing Approval Application or “MAA” shall mean, within the FG Territory, a New Drug Application or similar application as required under the U.S. Federal Food, Drug and Cosmetics Act and the regulations promulgated thereunder, or such similar filing in Europe, or a comparable filing for Marketing Approval in the Astellas Territory, in each case with respect to a Lead Compound for use within the Field.