Test Article means, in accordance with 21 C.F.R. § 50.3(j), any drug (including a biological product), medical device, food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act that is intended for administration to humans or animals, including a drug or biologic as identified in the Research Plan and Appendix B, that is used within the scope of the Research Plan. The Test Article may also be referred to as Investigational Agent, Study Material, or Study Product.

Test Article means any drug (in- cluding a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 and 354–360F of the Public Health Service Act (42 U.S.C. 262 and 263b–263n).

Test Article means any drug (including a biological product for human use), human food additive, colour additive, or other substance intended for administration to a human being;

Examples of Test Article in a sentence

If Collaborator terminates this Agreement before the completion of all approved or active Protocol(s), then Collaborator will supply enough Test Article (and Placebo, if applicable) to complete these Protocol(s) unless termination is for safety concerns.
At the completion of the Research Plan, any unused quantity of Test Article will be returned to Collaborator or disposed as directed by Collaborator.
Collaborator will provide a Certificate of Analysis to ICD for each lot of the Test Article provided.
Collaborator agrees to provide ICD without charge and on a schedule that will ensure adequate and timely performance of the research, a sufficient quantity of formulated and acceptably labeled, clinical-grade Test Article (and, as required by the Protocol(s), Placebo) to complete the clinical trial(s) agreed to and approved under this CRADA.
Furthermore, ICD agrees that no analysis or modification of the Test Article will be performed without Collaborator’s prior written consent.

More Definitions of Test Article

Test Article means, in accordance with 21 C.F.R. 50.3 (j), any drug (including a biological product), medical device, food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act that is intended for administration to humans or animals, including a drug or biologic as identified in the Research Plan and Appendix B, that is used within the scope of the Research Plan. The Test Article may also be referred to as Investigational Agent, Study Material, or Study Product. PHS ICT-CRADA Case Ref. No. _______ MODEL ADOPTED June 18, 2009

Test Article means any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to FDA regulation.

Test Article means any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product or any other article subject to regulation under the act or under Sections 351 or 354-360F of the Public Health Service Act. [21 CFR 50.3(j) and 21 CFR 56.102(l)]

Test Article means, in accordance with 21 C.F.R. 50.3 (j), any drug (including a biological product), medical device, food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act that is intended for administration to humans or animals, including a drug or biologic, as which for the purposes of the clinical studies to be conducted under this CRADA shall be the Tarmogens identified in the Research Plan and Appendix B,that is used within the scope-of-the Research Plan. The Test Article may also be referred to as Investigational Agent, Study Material, or Study Product. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Test Article means, in accordance with 21 C.F.R. § 50.3(j), any drug (including a biological product), medical device, food additive, color additive, electronic product, material or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301, et seq., Pub. L.No.75-717, 52 Stat. 1040 (1938), as amended. In this Agreement, JSP-191 is collectively referred to as the “Test Article”.

Test Article means any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, cosmetic, electronic product, or any other article subject to regulation under the act or under sections 351 or 354-360F of the Public Health Service A ct