Investigational New Drug definition

Investigational New Drug means a new chemical or biological entity or substance that has not been approved for marketing as a drug in any country;

Investigational New Drug or “IND” means an authorization from the FDA to administer an investigational drug or biological product to humans in clinical trials.

Investigational New Drug means a new drug or biological drug that is used in a Clinical Trial.

Examples of Investigational New Drug in a sentence

• To the extent required by applicable laws and regulations of the FDA, the Company or the applicable Subsidiary has submitted to the FDA an Investigational New Drug Application or amendment or supplement thereto for each clinical trial it has conducted or sponsored or is conducting or sponsoring; all such submissions were in material compliance with applicable laws and rules and regulations when submitted and no material deficiencies have been asserted by the FDA with respect to any such submissions.

• To the extent required by applicable Laws of the FDA, the Company or the applicable Subsidiary has submitted to the FDA an Investigational New Drug Application or amendment or supplement thereto for each clinical trial it has conducted or sponsored or is conducting or sponsoring; all such submissions were in material compliance with applicable Laws when submitted and no material deficiencies have been asserted by the FDA with respect to any such submissions.

• To the extent required by applicable laws and regulations of the FDA, the Company has submitted to the FDA an Investigational New Drug Application or amendment or supplement thereto for each clinical trial it has conducted or sponsored or is conducting or sponsoring; all such submissions were in material compliance with applicable laws and rules and regulations when submitted and no material deficiencies have been asserted by the FDA with respect to any such submissions.

• An investigational agent is a protocol drug administered under an Investigational New Drug Application (IND).

• State whether the 30-day interval between submission of applicant certification to the FDA and its response has elapsed or has been waived and/or whether use of the test article has been withheld or restricted by the FDA, and/or the status of requests for an Investigational New Drug (IND) or Investigational Device Exemption (IDE) covering the proposed use of the test article in the Research Plan.

More Definitions of Investigational New Drug

Investigational New Drug means chemical entity or substance which is under investigation in clinical trial regarding its safety and efficacy and which is required to be approved by the Central Drugs Authority;

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 New Drug or "IND" means an investigational new drug application (as defined in Title 21 of the United States Code of Federal Regulations, as amended from time to time) filed with the Federal Food and Drug Administration with regard to any Product.

Investigational New Drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms “investigational drug” and “investigational new drug” are deemed to be synonymous for purposes of this agreement.

Investigational New Drug means a new drug or biological drug that is used in clinical research and whose production and/or use is submitted to the FDA as an application. See, 21 CFR 312.3.

Investigational New Drug means a new drug or biological drug that is used in clinical research and whose production and/or use is submitted to the FDA as an application. See, 21 CFR 312.3. The RDRC must review human research protocols involving radioactive drugs that are without a New Drug Application (NDA) filed with the FDA, or an approved Investigational New Drug (IND) application (an IND Exemption may be subject to review by the RDRC in compliance with 21 CFR 361.1.)

Investigational New Drug means "AIDSVAX(TM)", a vaccine consisting of one or more gp120 antigens plus the adjuvant alum or placebo containing adjuvant alum.