IND means (a) 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 agency 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 means any investigational new drug application, clinical trial application, clinical trial exemption or similar or equivalent application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.
IND means an Investigational New Drug Application (as defined in the Food, Drug and Cosmetic Act, as amended) filed with the FDA or any equivalent application for authorization to commence human clinical trials in other countries or regulatory jurisdictions.
Examples of IND in a sentence
SHARING After the Effective Date, and at a time to be agreed upon by ONCOX and RGENE in the Definitive Agreement, RGENE would transfer to ONCOX in English that data related to any Licensed Products in RGENE’s possession and control that is required by regulatory authorities for opening an IND, NDA.
SHARING After the Effective Date, and at a time to be agreed upon by XXXXX and ABVC in the Definitive Agreement, ABVC would transfer to ONCOX in English that data related to any Licensed Products in ABVC’s possession and control that is required by regulatory authorities for opening an IND, NDA.
XXXXX shall be responsible for completing regulatory filing of IND in the Territory.
More Definitions of IND
IND means an investigational new drug application filed with an applicable FDA Foreign Equivalent or other applicable Regulatory Authority with respect to a Product (or other compound, product or therapy).
IND means an investigational new drug application filed with the FDA for approval to commence human clinical trials, and its equivalent in other countries or regulatory jurisdictions in the Territory.
IND means any 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 Regulatory Authorities in the European Union.
IND means an Investigational New Drug application filed with the FDA in accordance with Applicable Law.
IND means: (a) in the United States, an Investigational New Drug application (as more fully described in 21 CFR Part 312, or its successor regulation), filed with the FDA, or any successor application to the foregoing; or (b) in any other country or group of countries, the equivalent application or filing filed with the governing Regulatory Authority in such country or group of countries necessary to commence human clinical trials in such jurisdiction.
IND means an investigational new drug application (including any amendment or supplement thereto) submitted to the FDA pursuant to U.S. 21 C.F.R. Part 312, including any amendments thereto. References herein to IND shall include, to the extent applicable, any comparable filing(s) outside the U.S. for the investigation of any product in any other country or group of countries (such as a Clinical Trial Application (“CTA”) in the EU).
IND means an “Investigational New Drug Application”, filed in accordance with 21 C.F.R. Part 312 under which clinical investigation of an experimental drug or biologic (Test Article) is performed in Human Subjects in the United States or intended to support a United States licensing action.