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)”.
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. ▇▇-▇-▇▇▇▇▇ Page 5 of 33 Confidential
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.
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.