NDA
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 defined in the United States Federal Food, Drug and Cosmetics Act and the regulations promulgated thereunder, where such application is for a Licensed Product
NDA. Defined in the License Agreement
NDA. A New Drug Application or application for approval to market submitted to the FDA
Found in
Assertio Therapeutics, Inc contract
NDA. Shall mean the Mutual Non-Disclosure Agreement, dated July 29, 2013, entered into by and among Cytori, and Bimini, and attached hereto as Exhibit D.
All Definitions
Found in
CYTORI THERAPEUTICS, INC. contract