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 (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.

Examples of Clinical Hold in a sentence

• 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.

• 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.

• Clinical Hold and Current StatusAs previously disclosed, the Phase Ib trial was placed on clinical hold in order to solve a chemistry-based formulation issue, and the chemistry of the API and the formulation had undergone minor modifications to deliver a stable and soluble drug product for return to the clinical setting.

• 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)).

More Definitions of Clinical Hold

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 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 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. 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.

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 there are regulatory restrictions in place from FDA preventing the sale and distribution of OpenBiome FMT Product by Seller under enforcement discretion.