Clinical Trial Application definition

Clinical Trial Application means a submission made to the applicable Innovate Regulatory Agency or Company Regulatory Agency, the purpose of which is to gain necessary clearance, licensure, or approval by such agency to lawfully distribute a product to perform a human clinical trial of such product that at the time of such submission is not otherwise lawfully able to be distributed or marketed in interstate commerce under the laws of the relevant jurisdiction.

Clinical Trial Application or “CTA” means an application to a regulatory or other government agency as necessary to perform human clinical trials in conformance with Applicable Laws.

Clinical Trial Application means an application to carry out a Clinical Trial.

Examples of Clinical Trial Application in a sentence

• The Company’s Canadian Clinical Trial Application (“CTA”) submission to Health Canada was subsequently also accepted.

• In Canada, a Clinical Trial Application (“CTA”) must be submitted to Health Canada at least 30 days prior to commencement of each clinical trial and in some cases written approval must be obtained prior to commencement of a specific clinical trial.

• STORAGE REQUIREMENTS: Storage will be pursuant to FDA and current ARC regulations but must also comply with requirements specified in the clinical trial Investigational Drug Application and Clinical Trial Application and be maintained at room temperature out of any direct sunlight or other severe conditions.

• In September 2006, a Clinical Trial Application relating to our Generex Oral-lyn™ protocol for late-stage trials was approved by Health Canada.

• Cellectis shall prepare, file and prosecute all regulatory applications useful or necessary to obtain approvals at Cellectis name to develop the Candidate Product up to Phase 1 (e.g. Clinical Trial Application or equivalent), based on the Development Plan as previously agreed by the JSC.

More Definitions of Clinical Trial Application

Clinical Trial Application or “CTA” has the meaning accorded this term in accordance with the requirements of Health Canada, including all amendments and supplements to such application, or any IND or other equivalent filing with any other Regulatory Authority.

Clinical Trial Application means an effective Notice of a Claimed Investigational New Drug Exemption, as defined in Title 21 of the Code of Federal Regulations, on file with the FDA before the commencement of clinical trials of Licensed Products in humans, or any comparable filing with any relevant regulatory agencies or other governmental entities in any country in the Territory.

Clinical Trial Application or “CTA” has the meaning set forth in Section 1.89.

Clinical Trial Application means an Investigational New Drug Application for any Product filed with the FDA pursuant to Title 21 of the Code of Federal Regulations, Part 312 (“IND”) or the submission to a competent Regulatory Authority within the EU of a request for an authorization concerning a clinical trial, as envisaged in Article 9, paragraph 2, of Directive 2001/20/EC, or any comparable filing made with a Regulatory Authority in another country or territory other than the U.S. or the EU.

Clinical Trial Application means a document used to request authorization from a Regulatory Authority to begin testing an experimental compound/drug in patients.

Clinical Trial Application means the application dossier for the commencement of a clinical trial, to be submitted to the competent authorities of any member state of the EU and the relevant ethics committee, consisting of administrative information and the necessary demonstration of quality, safety and efficacy of an investigational medicinal product.

Clinical Trial Application means any and all applications to the European Medicines Agency or other appropriate Regulatory Health Authorities for the permission to perform a clinical study as required by Applicable Law.