Registrational Clinical Trial means any one of a Phase III clinical trial or pivotal Phase II clinical trial conducted in furtherance of Regulatory Approvals.
Registrational Clinical Trial means a human clinical trial of a Licensed Product that: (a) would satisfy the requirements of 21 C.F.R. § 312.21(c) or corresponding foreign regulations; or (b) that if successful would provide sufficient efficacy data to support the filing of an MAA for such Licensed Product in such country.
Registrational Clinical Trial means, with respect to a Licensed Product, either (a) a Phase III Clinical Trial for such Licensed Product or (b) a pivotal Phase II Clinical Trial, in each case that, at the time of commencement, is expected to provide an adequate basis for the preparation and submission of a BLA or NDA to obtain Marketing Approval of such Licensed Product in a Major Market.
Examples of Registrational Clinical Trial in a sentence
One thing I noticed on Friday was simply the excess in which our com- munity eats.
A first year pitcher must throw one (1) complete inning from opening day until May 1st.
ATHX may terminate this Agreement immediately by notice to CHUGAI in the event that after completion of a Pivotal Registrational Clinical Trial in the Territory CHUGAI fails to pay any of the remaining amounts due under Sections 7 and 8 and fails to rectify such breach within sixty (60) days of written notice of such breach from ATHX, but not for any other material breach (for which all remedies other than termination remain available).
ATHX may terminate this Agreement immediately by notice to CHUGAI in the event that before completion of a Pivotal Registrational Clinical Trial in the Territory CHUGAI is in material breach of this Agreement and fails to rectify such breach within sixty (60) days of written notice of such breach from ATHX.
Further, I understand that DHS has regulations in place that are consistent with Supreme Court precedent (Zadvydas v.
More Definitions of Registrational Clinical Trial
Registrational Clinical Trial means, with respect to a given Product, either: (a) a Phase III Clinical Trial with such Product; or (b) a Phase IIb Clinical Trial that, at the time of commencement, is expected to be the basis for initial Regulatory Approval of such Product.
Registrational Clinical Trial means, in respect of a Product, either (a) a Phase 3 Clinical Trial for such Product or (b) a registration trial sufficient for filing an MAA for such Product with the FDA or the EMA as evidenced by (i) an agreement with, or statement from, the FDA or the EMA on a special protocol assessment or its equivalent, or (ii) other guidance or minutes issued by the FDA or EMA, for such registration trial.
Registrational Clinical Trial means any a clinical trial, or arm thereof, in human subjects that has been approved by an institutional review board or ethics committee, as applicable, of any product that would satisfy the requirements of 21 C.F.R. § 312.21(c) or corresponding foreign regulations, regardless of whether such trial is referred to as a “Phase III Clinical Trial”, that is intended (as of the time such clinical trial is initiated) to obtain data and results necessary to support the filing of an application for Regulatory Approval (but may not include the data that may be necessary to support the pricing and/or reimbursement approvals).
Registrational Clinical Trial means, with respect to a Licensed Product, a clinical trial that is expected, based on guidance from the FDA or other applicable Regulatory Authority, to provide the basis for submitting an application for Regulatory Approval for such Licensed Product (whether it be for the first Regulatory Approval for that Licensed Product or expansion of that Regulatory Approval to include an additional indication for such Licensed Product). For avoidance of doubt, a clinical trial or portion thereof may be a Registrational Clinical Trial regardless of whether the protocol for such clinical trial describes it as a “Phase 1,” “Phase 2,” or “Phase 3” clinical trial, or any variation thereof.
Registrational Clinical Trial means: (a) a human clinical trial of a compound or product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(c) or corresponding foreign regulations or (b) a human clinical trial of a compound or product that is intended to: (i) establish that the compound or product is safe and efficacious for its intended use; (ii) define contraindications, warnings, precautions, and adverse reactions that are associated with the compound or product in the dosage range to be prescribed; and (iii) support Regulatory Approval for such compound or product (whether conditional or final), but may not include the data that may be necessary to support the Pricing and Reimbursement Approvals; or (c) a human clinical trial similar to a human clinical trial described in sub-clause (a) prescribed by the relevant Regulatory Authorities in a country other than the United States.
Registrational Clinical Trial means a Phase III Clinical Trial or other Clinical Trial or portion of a Clinical Trial (however denominated) with a defined dose or a set of defined doses of a pharmaceutical product or combination regimen designed to ascertain efficacy and safety of such product or combination regimen for the purpose of enabling the preparation and submission of an NDA.
Registrational Clinical Trial means a Clinical Trial that is designed to, and for which the competent Regulatory Authority has provided guidance that the design of such Clinical Trial is sufficient to, ascertain efficacy and safety of an intervention in support of the preparation and submission of an NDA for such intervention to such competent Regulatory Authority, regardless of whether such trial is referred to as a Phase 2(b) Clinical Trial or Phase 3 Clinical Trial. If a Clinical Trial of an intervention is not initially designed as a Registration Clinical Trial but is later re-designed, converted or expanded into such a trial, then it shall be deemed to be a Registration Clinical Trial as of the date of such re-design, conversion or expansion.