IND Submission definition

IND Submission means an "Investigational New Drug" application to the FDA requesting approval to initiate a clinical trial on a new drug or biological product.
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IND Submission with respect to a Venture Product means submission of an Investigational New Drug regulatory application ("Chiken Todoke" corresponding to an IND application in the U.S.) to authorities for approval to initiate any new phase of human trials of the product in a jurisdiction in the Territory.
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IND Submission means the submission of an IND to a Regulatory Authority in a Major Market Country.
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Examples of IND Submission in a sentence

  • IND Submission Updates and FDA Meetings This task will include submissions to the IND and possible FDA meetings that will be required prior to the BLA submission.

  • The Joint Steering Committee shall evaluate the Proposed IND Submission and proposed Clinical Work Plan, and any comments provided by Genmab and attempt, with the understanding that time and cost is of the essence (while at all times adhering to and complying with quality and regulatory requirements), to include in the initial versions of the Proposed IND Submission and the Clinical Work Plan and budgets any input provided by either Party that keep the Clinical Work Plan within the Clinical Plan Framework.

  • Gadsden State Community College alumna has quite an impressive resume with multiple accolades as one of the premiere softballcoaches in the state.

  • In case ADCT is the Withdrawing Party prior to providing the IND Submission and Clinical Work Plan, and Genmab does not elect to be the Continuing Party, then notwithstanding the above, Genmab may at its sole discretion decide that the Divestment Process as set forth in Article 9 shall not be initiated and that the Agreement be terminated.

  • The JRDC shall assess the status of such Preclinical Development Activities, and, if a Development Candidate meets the IND Submission Criteria, or if the JRDC otherwise determines that an IND should be submitted for a Development Candidate, then the JRDC shall nominate such Development Candidate for IND submission to [ * ].

  • Once the Proposed IND Submission has been approved by the JSC pursuant to Section 5.1.2(a), the [**] shall not be changed.

  • Genmab shall also be entitled to get access to all regulatory packages related to the Proposed IND Submission and the CMC related matters and provide input on such packages and matters, where relevant as well as all official Food and Drug Administration minutes for informational purposes.

  • ADCT may tile the final version of the Proposed IND Submission with the Regulatory Authority as the IND.

  • Once such an IND submission package has been agreed on by the Joint Steering Committee, Proposed IND Submission for the purposes of Section 14 and the financial terms set forth in Exhibit 1 shall be deemed reached.

  • In the second task the en- tailed feedback was ranked higher in three cases.2 Additionally, there were some cases in which the annotators did not annotate the entailed feedback at all, which in itself might indicate that it is treated as less prominent by inexperienced anno- tators.


More Definitions of IND Submission

IND Submission means the submission by the Company of its first IND for G-202 as confirmed by the assignment of an IND number by the FDA.
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IND Submission means the collection, assembly and presentation of an Investigational New Drug application, or equivalent, to a Regulatory Authority in support of a first-in-man Phase I Trial and which has been accepted by the Regulatory Authority, thereby allowing the Phase I Trial to commence.
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IND Submission means the submission of an IND for the Licensed Product with the relevant Regulatory Authority.
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Related to IND Submission

  • 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.

  • DMF means a drug master file, as provided for in 21 CFR § 314.420 or similar submission to or file maintained with the FDA or other Governmental Authority or Regulatory Authority that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

  • Program of study means a curriculum that requires a candidate to demonstrate and document competency in the specific knowledge, skills, and dispositions for a particular endorsement to an educator’s license, a licensure content area, or level of licensure, and is:

  • Regulatory Materials means regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals or other filings made to, received from or otherwise conducted with a Regulatory Authority in order to Develop, Manufacture, or Commercialize a Licensed Product in a particular country or jurisdiction.