IND
IND. Shall mean an investigational new drug application, clinical study application, clinical trial exemption or similar application or submission for approval to conduct human clinical investigations filed with a Regulatory Authority in any country.
IND. The Investigational New Drug Application filed or to be filed with the FDA as described in Title 21 of the U.S. Code of Federal Regulations, Part 312, and the equivalent application in the jurisdictions outside the United States, including an Investigational Medicinal Product Dossier filed or to be filed with the EMA.
Found in
Replimune Group, Inc. contract
IND. Means an Investigational NDA in the Territory filed with the FDA.
Found in
Vanda Pharmaceuticals Inc. contract
IND. Means an investigational new drug application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA or (b) the equivalent application to the equivalent Regulatory Authority in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.
IND. An Investigational New Drug application required to commence human clinical testing of a product submitted to the FDA
Found in
HARROW HEALTH, INC. contract
IND. An Investigational New Drug application for a Licensed Product submitted to the FDA or a comparable application submitted to another Regulatory Agency.
IND. An investigational new drug application (Form FDA 1571) or any successor form or foreign equivalent.
Found in
DNIB UNWIND, INC. contract
IND. An investigational new drug application and associated documents required to be filed with the FDA or a comparable government agency outside of the United States to obtain approval to commence human clinical trials of a Product.
IND. The designation of Licensed Product as an Investigational New Drug on the basis of a Cell Cure-initiated application as described in 21 C.F.R. Section 312.23, filed for purposes of conducting a Phase I Clinical Trial in accordance with the requirements of the United States Food, Drug and Cosmetic Act of 1938, as amended, and the rules and regulations promulgated thereunder, including all supplements and amendments thereto, which may include, inter alia, managing animal studies, as well as...
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BIOTIME INC contract
IND. The term "IND" shall mean an investigational new drug application as defined by 21 CFR Part 312.
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Found in
Sorrento Therapeutics, Inc. contract