IND
IND. Means an Investigational New Drug Application filed with the FDA or the equivalent application or filing filed with any equivalent agency or government authority outside of the United States (including any supra-national agency such as in the European Union) necessary to commence human clinical trials in such jurisdiction, and including all regulations at 21 CFR § 312 et. esq., and equivalent foreign regulations.
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. Means an investigational new drug application (as defined in Title 21 of the United States Code of Federal Regulations, as amended from time to time) filed or to be filed with the FDA.
Found in
HYB Holding Corp. contract
IND. Means an investigational new drug application filed with the United States Food and Drug Administration (or its foreign equivalent) prior to beginning clinical trials in humans or any comparable application filed with the regulatory authorities of a country other than the United States, prior to beginning clinical trials in humans in that country; provided however, that for purposes of this definition, an IND shall not include an investigational new drug application regarding the testing of...
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Found in
ARQULE INC contract
IND. Means an investigational new drug application as defined in 21 C.F.R. Section 312 et seq for the FDA in the United States or equivalent application to other countries, to commence clinical testing of a drug in humans, as defined by the FDA in the United States, or other applicable Competent Authority, as the same may be amended, supplemented or replaced from time to time.
Found in
ENHANCE BIOTECH INC contract
IND. Shall mean an Investigational New Drug Application to the FDA to commence human clinical testing of a Product, as defined by the FDA, or the equivalent application in any country or jurisdiction other than the United States.
Found in
CURIS INC contract
IND. Means Investigational New Drug application, the compilation of clinical and non-clinical data, including all amendments and additions, as described in Title 21,United States Code of Federal Regulations section 312.3 (21 C.F.R. ' 312.3) or comparable definitions in other countries, by which a party may conduct human studies of therapeutic compounds.
Found in
POZEN INC contract
IND. Means Investigational New Drug.
Found in
DENDREON CORP contract
IND. Means an Investigational New Drug Application filed pursuant to the requirements of the United States Food and Drug Administration as more fully defined in 21 C.F.R. Section 312 or its foreign equivalent. *Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 2
IND. Shall mean the application with the regulatory authority required in a particular country in relation to a product in order that such product may be used for investigational clinical use with human subjects notwithstanding that the local name for such an application may be different.
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Found in
IVAX CORP contract