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.
Sample 1

Examples of Formulary Agent in a sentence

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

  • 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 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.

  • 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.

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

  • 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.

  • Furthermore, NCI will ensure that no analysis or modification of the Formulary Agent will be performed by Approved Investigators without Collaborator’s prior written consent.

  • 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.

  • 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.

  • In addition, NCI will ensure that the Formulary Agent (and all Confidential Information supplied by Collaborator relating to the Formulary Agent) will be used solely for the conduct of the CRADA Research Plan.

Related to Formulary Agent

  • Practice of pharmacy means providing pharmacist care requiring specialized knowledge, judgment, and skill derived from the principles of biological, chemical, behavioral, social, pharmaceutical, and clinical sciences. As used in this division, "pharmacist care" includes the following:

  • Participating Pharmacy means a pharmacy that has entered into a prescription drug plan agreement with the Pharmacy Benefit Manager listed on your identification card.

  • PCU means the Project coordinating unit referred to in Section 3.04 of this Agreement;

  • Marketing Agent means MACRO Financial, LLC, in its capacity as marketing agent hereunder, and its successors and assigns.

  • Distributor representative means a representative similarly employed by a distributor, distributor branch, or wholesaler.

  • Formulary means a list of covered prescription drugs provided under this plan. The formulary includes generic, preferred brand name, non-preferred brand name, and specialty prescription drugs.

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

  • Raptor means all birds of the orders Falconiformes and Strigiformes, commonly called falcons,

  • Certified pharmacy technician or “certified technician” means an individual who holds a valid current national certification and who has registered with the board as a certified pharmacy technician.

  • Medical Advise means any consultation or advice from a Medical Practitioner including the issue of any prescription or repeat prescription.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • ANI means automatic number identification.

  • LTC shall have the meaning set forth in the introductory paragraph hereof.

  • Input Service Distributor means an office of the supplier of goods or services or both which receives tax invoices issued under section 31 towards the receipt of input services and issues a prescribed document for the purposes of distributing the credit of central tax, State tax, integrated tax or Union territory tax paid on the said services to a supplier of taxable goods or services or both having the same Permanent Account Number as that of the said office;

  • Practice of chiropractic means the adjustment of the 24 movable vertebrae of the spinal column,

  • Technical Advisory Committee means the external committee to be established and appointed by the Steering Committee to provide technical input for decisions to be taken by the Steering Committee; and

  • Dissemination Agent means the Trustee, acting in its capacity as Dissemination Agent, or any successor Dissemination Agent designated in writing by the City and which has filed with the Trustee a written acceptance of such designation.

  • Medical Advisory Committee means the Medical Advisory Committee established by the Board as required by the Public Hospitals Act;

  • Distributor means a person who distributes.

  • Participating Prescription Drug Provider means an independent retail Pharmacy, chain of retail Pharmacies, mail-order Pharmacy or specialty drug Pharmacy which has entered into an agreement to provide pharmaceutical services to participants in the benefit program. A retail Participating Pharmacy may or may not be a select Participating Pharmacy as that term is used in the Vaccinations Obtained Through Participating Pharmacies section.

  • Recall means any measure aimed at achieving the return of a device that has already been made available to the end user;

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Medication error means any preventable event that may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems including, but not limited to: prescribing; order communication; product labeling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.

  • Medication means any drug, chemical, compound, suspension, or preparation in suitable form for use as a curative or remedial substance taken either internally or externally by any person.

  • Billing agent means a telephone utility that includes in a bill it sends to a customer a charge for a product or service offered by a service provider.[PL 1999, c. 59, §1 (NEW); PL 1999, c. 59, §3 (AFF).]

  • Novartis shall have the meaning set forth in the Preamble.