Formulary Agent definition

Formulary Agent or “Investigational New Drug” or “Investigational Agent” 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, Formulary Agent means agent(s), provided by or on behalf of the Provider Collaborator under a Cooperative Research and Development Agreement (“CRADA”) between Provider and the Collaborator. The Formulary Agent(s) may also be used in non-clinical, preclinical lab studies as part of a Proposal under this Agreement.
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Examples of Formulary Agent in a sentence

  • For purposes of this requirement, a product complaint is any written, electronic, or oral communication that alleges deficiencies of a Formulary Agent or drug delivery system related to: (1) identity, (2) performance, (3) reliability, (4) safety, (5) quality, (6) durability, (7) purity, or (8) effectiveness.

  • An initial draft version of the Formulary Protocol must be submitted to the NCI at the same time it is provided to NCI Collaborator for Formulary Agent forecasting purposes.

  • For the purposes of this Agreement, completion of a protocol is defined as all patients having completed treatment with the Formulary Agent.

  • Collaborator may terminate the CRADA at its option and suspend supply of Formulary Agent if the Approved Investigators fails to meet patient accrual goals.

  • Institution will notify NCI Collaborator within twenty-four (24) hours of Approved Investigator and/or Institution receiving notification or becoming aware of any product complaint related to a Formulary Agent.

  • If Possible, NCI prefers the NCI NSC (National Service Center) number for the Formulary Agent to be on the label.

  • If Collaborator terminates this Agreement before the completion of all approved or active Protocol(s), then Collaborator will supply enough Formulary Agent to complete these Protocol(s) unless termination is for safety concerns, lack of enrollment, or other mutually agreed reasons.

  • At the completion of the Research Plan, any unused quantity of Formulary Agent in NCI’s possession will be returned to Collaborator, at Collaborator’s expense, or disposed as directed by Collaborator.

  • If corrective action is met, Collaborator will be responsible for supplying sufficient Formulary Agent to complete the applicable Study, if corrective action is not met the Study may be terminated at Collaborator’s discretion.

  • NCI will ensure that the Approved Clinical Investigators are required to keep appropriate records and take reasonable steps to ensure that the Formulary Agent is used in accordance with the Protocol(s), Proposal(s), and applicable FDA regulations.