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 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 Study Drug 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.

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.

• Manual of Standard Operating Procedures and Policies Investigational New Drug; Issuance of and Response to Clinical Hold Letters for Investigational New Drug Applications, SOPP 8201, Version #3, April 27, 1999, http://www.fda.gov/cber/regsopp/8201.htm.

• Form FDA 3926 may also be used for certain follow-up submissions to an individual patient expanded access IND, which include the following: Initial Written IND Safety Report(§ 312.32(c)); Follow-up to a Written IND Safety Report (§ 312.32(d)); Annual Report(§ 312.33); Summary of Expanded Access Use (treatment completed) (§ 312.310(c)(2)); Change in Treatment Plan (§ 312.30); General Correspondence or Response to FDA Request for Information (§ 312.41); and Response to Clinical Hold (§ 312.42(e)).

• 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.

More Definitions of Clinical Hold

Clinical Hold means, in the U.S., an order issued by FDA to the sponsor of a Clinical Trial to delay or suspend, in full or in part, an ongoing Clinical Trial, as set forth in 21 U.S.C. §312.42, or outside of the U.S., the foreign equivalent thereof issued by the applicable Regulatory Authority.

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 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 THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 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 as used in this Section 12.7A, shall mean a bona fide decision of IPH 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 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 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 (i) an order issued by the FDA 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 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WHERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. States or (ii) an equivalent order to that set forth in (i) issued by a Regulatory Authority other than the FDA in any other country or group of countries.