Investigational Agent definition

Investigational Agent or “Investigational New Drug” means, in accordance with the definition in 21 C.F.R. § 312.3, a new drug or biological drug that is used in a clinical investigation. For this Agreement, Investigational Agent means Collaborator’s proprietary investigational agents as listed in Attachment A, provided by or on behalf of Collaborator. For the purpose of this CRADA, Investigational Agent(s) will be referred to as “Formulary Agent(s)”.
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Investigational Agent or Investigational New Drug means, in accordance with the definition in 21 C.F.R. § 312.3, a new drug or biological drug that is used in a clinical NCI DCTD CRADA model adopted October 14, 2011 Case Ref. No. 00-0-00000 Page 5 of 33 Confidential
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Investigational Agent means, for purposes of this CRADA, and in accordance with 21 C.F.R. § 312.3 , the drug candidate 1-methyl-D-tryptophan (also known as 1MT, or NSC721782), which is provided by or on behalf of Collaborator.
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Examples of Investigational Agent in a sentence

  • An example of typical terms for an MTA for the transfer of Investigational Agent from NCI to Approved Investigator for conducting any approved Protocol or Proposal is attached as Appendix B.

  • Collaborator will ship the Investigational Agent to NCI or its designee in containers marked in accordance with 21 C.F.R. § 312.6 for any Protocol(s) of the CRADA.

Related to Investigational Agent

  • Investigation means the Bureau’s decision to hold and not process the Company’s license renewal applications identified in Appendix A due to the Company’s inability to certify compliance with its public file obligations.

  • Authority Representative means the representative appointed by the Authority from time to time in relation to this Framework Agreement;

  • Background investigation means the investigation conducted by a licensee or applicant to support the determination of trustworthiness and reliability.

  • Investigations The Xxxxxxx, when requested by one or a number of employees whom he/she represents, may investigate the basis for any dispute arising under this Agreement and may, at any stage, assist the employee(s) in seeking resolution of such dispute through the grievance procedure provided herein. A representative of the Union may substitute in place of the Xxxxxxx.

  • Educational Agency means a school district, board of cooperative educational services (BOCES), school, or the New York State Education Department (NYSED).

  • Contractor Representative means any of the following:

  • District Representative means the Superintendent of the District, or any other person authorized by the Governing Board of the District to act on behalf of the District under or with respect to this Facilities Lease.

  • Gestational age or "gestation" means the age of an unborn child as calculated from the first day of the last menstrual period of a pregnant woman;