Clinical Trial Application or “CTA” means an application to a Regulatory Authority for purposes of requesting the ability to start or continue a clinical trial, which CTA may consist of, or include, an IND or IMPD, as applicable.
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 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.
Examples of Clinical Trial Application in a sentence
To the Knowledge of the Obligors there are no other facts or circumstances that could reasonably be expected to (A) indicate that any of the events specified in the immediately preceding clauses (i), (ii) or (iii) may occur or (B) cause the Obligors or any of their respective Affiliates or Licensees to voluntarily revise, withdraw or not apply for any Clinical Trial Application or Regulatory Approval for Anktiva.
More Definitions of Clinical Trial Application
Clinical Trial Application means an application to carry out a Clinical Trial.
Clinical Trial Application or “CTA” has the meaning set forth in Section 1.76 (“IND”).
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 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 a document used to request authorization from a Regulatory Authority to begin testing an experimental compound/drug in patients.
Clinical Trial Application means any application or submission to any Regulatory Agency for authorization to conduct a Clinical Trial of any Included Product in any country or group of countries.
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.