Clinical Hold definition

Clinical Hold means that (a) the FDA has issued an order to a Party pursuant to 21 CFR §312.42 to delay a proposed clinical investigation or to suspend an ongoing clinical investigation of the Combined Therapy or such Party’s Single Agent Compound in the United States or (b) a Regulatory Authority other than the FDA has issued an equivalent order to that set forth in (a) in any other country or group of countries.

Clinical Hold means a clinical hold issued by the FDA (or other Regulatory Authority) in accordance with 21 CFR 312.42 (or a similar foreign counterpart law or regulation) to delay a proposed clinical investigation of a Product or to suspend an ongoing clinical investigation of a Product.

Clinical Hold means that (a) the applicable Clinical Trial is put on clinical hold by the applicable Regulatory Authorities and remains on hold for at least one year, (b) the IND or other regulatory approval for the applicable Clinical Trial has been suspended, terminated, or withdrawn by the applicable Regulatory Authorities and remains suspended, terminated, or withdrawn for at least one year, (c) the applicable Clinical Trial has been suspended due to potential toxicity or safety findings or side effects that the Joint Development Committee (with the consent of both Parties) reasonably believes justify suspension of such Clinical Trial, or (d) due to potential toxicity or safety findings or side effects, the independent data monitoring committee recommends termination of such Clinical Trial.

Examples of Clinical Hold in a sentence

• Refer to SOPP 8201, “Issuance of and Response to Clinical Hold Letters for Investigational New Drug Applications” (Ref.

• If an Xxxxxxxxx Xxxxx 0 Clinical Trial is put on Clinical Hold, the Joint Development Committee shall modify the budget to appropriately reflect the costs associated with the wind-down of activities associated with the applicable Xxxxxxxxx Xxxxx 0 Clinical Trial.

• For a further description of "On Clinical Hold," see "-- Products and Products Under Development -- Autoimmune and Inflammatory Products -- PRIMATIZED IDEC-151 and IDEC-CE9.1. (2) Although Phase I trials have been completed, the Company does not intend to pursue further development unless and until it enters into a partnering arrangement for such development.

• A SIR should include clear, specific questions regarding review issues relevant to the planned response to the pending marketing submission hold letter (e.g., questions regarding non-clinical and clinical testing protocols or data needed to support the submission), IND Clinical Hold, or IDE letter, including identification of the deficiencies to be discussed, in order to focus FDA and submitter efforts on issues most relevant to moving a project forward.

• If, after [ ]* of discussions following the Clinical Hold, either Party reasonably concludes that the issue adversely impacts the Combined Therapy Clinical Trial and is not solvable or that unacceptable and material additional costs/delays have been and/or will continue to be incurred in the conduct of the Combined Therapy Clinical Trial, then such Party may immediately terminate this Agreement.

More Definitions of Clinical Hold

Clinical Hold means that (i) the FDA has issued an order to a Party pursuant to 21 CFR §312.42 to delay a proposed clinical investigation or to suspend an ongoing clinical investigation of the Combined Therapy or such Party’s Single Agent Compound in the United States or (ii) a Regulatory Authority other than the FDA has issued an equivalent order to that set forth in (i) in any other country or group of countries.

Clinical Hold means the FDA requires Amylin to stop, or Amylin agrees to stop, dosing patients with Compound in all Amigo Trials, prior to completion of the Amigo Trials in accordance with their protocols.

Clinical Hold means that (a) the FDA has issued an order to a Party pursuant to 21 CFR §312.42 to delay a proposed clinical investigation or to suspend an ongoing clinical investigation of the Combined Therapy or such Party’s Compound in the United States or (b) a Regulatory Authority other than the FDA has issued an equivalent order to that set forth in (a) in any other country or group of countries.

Clinical Hold as used in this Section 12.7, shall mean a bona fide decision of the developing Party or a decision of a regulatory authority or another governmental body to suspend a clinical trial or other study when it does not believe that such clinical trial or other study can be conducted without unreasonable risk to the subjects in such clinical trial or study, and the existence of such circumstances shall be subject to arbitration in accordance with Section 21.14.

Clinical Hold means that (a) the applicable Clinical Trial is put on clinical hold by the applicable Regulatory Authorities and remains on hold for at least one year, (b) the IND or other regulatory approval for the applicable Clinical Trial has been suspended, terminated, or withdrawn by the applicable Regulatory Authorities and remains suspended, terminated, or withdrawn for at least one year, (c) the applicable Clinical Trial has been suspended due to potential toxicity or safety findings or side effects that the Joint Development Committee (with the consent of both Parties) reasonably believes justify suspension of such Clinical Trial, or(d) due to potential toxicity or safety findings or side effects, the independent data monitoring committee recommends termination of such Clinical Trial.

Clinical Hold means the FDA’s clinical hold on the investigational new drug application for the Company’s Phase 2/3 ReMEDy2 clinical trial studying the use of the Company’s product candidate, DM199, to treat acute ischemic stroke patients.

Clinical Hold. Clinical Hold shall mean a complete or partial clinical hold as described in the “Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds”, dated October 2000, revision 1, as available at xxxx://xxx.xxx.xxx/RegulatoryInformation/Guidances/xxx000000.htm as of the Effective Date.