NDA
NDA. A New Drug License approval application, as defined in the Act, and the regulations promulgated thereunder
Found in
NOVELION THERAPEUTICS INC. contract
NDA. A New Drug Application, as defined in the United States Federal Food, Drug and Cosmetic Act, as amended, and all regulations promulgated thereunder
Found in
ADIAL PHARMACEUTICALS, INC. contract
NDA. A New Drug Application or its equivalent (and including any amendments or supplements thereto) that is filed pursuant to the requirements of the FDA, as defined in 21 C.F.R. § 314 et seq., to obtain FDA approval to commercialize a pharmaceutical product in the United States.
Found in
Clovis Oncology, Inc. contract
NDA. A new drug application filed with the FDA as more fully defined under 21 C.F.R. § 314.50 et. seq.
Found in
Evoke Pharma Inc contract
NDA. Any or all applications (New Drug Application) submitted to the FDA under sections 505, 507, or 512 of the Food, Drug & Cosmetic Act and applicable regulations related to a product, and any equivalent foreign filing
Found in
MEDICINOVA INC contract
NDA. Means New Drug Application or any comparable application required by a Foreign Jurisdiction filed for the Product by CLIENT with the FDA and all subsequent submissions, supplements or amendments related thereto.
Found in
HALOZYME THERAPEUTICS INC contract
NDA. Means a New Drug Application submitted and filed with the FDA as more fully defined in 21 C.F.R. § 314.5 et seq., including but not limited to such an application filed under Section 505(b)(2) of the United States Federal Food, Drug and Cosmetic Act, as amended.
NDA. 505(b)(2) New Drug Application for Orapred ODT listed in Exhibit A
Found in
BIOMARIN PHARMACEUTICAL INC contract
NDA. The term "NDA" shall mean a New Drug Application, as defined in the United States Food, Drug & Cosmetic Act and applicable regulations promulgated thereunder, as amended from time to time, to obtain approval from the FDA for commercial sale of a Product, or an equivalent application or filing with the applicable Regulatory Authority in any country other than the United States.
NDA. A New Drug Application (as more fully defined in 21 C.F.R. 314.5 et seq.) and all amendments and supplements thereto filed with the FDA, or the equivalent application filed with any equivalent agency or governmental authority outside the United States of America (including any supra-national agency such as in the European Union), including all documents, data, and other information concerning a pharmaceutical product which are necessary for gaining regulatory approval to market and sell such...
View More
All Definitions
