Complete Response Letter definition

Complete Response Letter means a written communication from the FDA that satisfies the definition therefor set forth in 21 C.F.R. Part 314, Subpart A, as may be amended from time to time, or any successor to such written communication.

Complete Response Letter means a letter received from the FDA pursuant to 21 CFR 314.110 of the United States Code of Federal Regulations.

Complete Response Letter means awritten communication to an applicant from FDA usually describing all of the deficiencies that the agency has identi- fied in a biologics license application or supplement that must be satisfac- torily addressed before it can be ap- proved.

Examples of Complete Response Letter in a sentence

• On July 7, 2016, the Company announced it received a Complete Response Letter stating the sNDA cannot be approved in its present form and requested additional information.

• On July 7, 2016, the Company received a Complete Response Letter stating the sNDA cannot be approved in its present form and requested additional information.

• A Complete Response Letter indicates that the review cycle of the application is complete and the application is not ready for approval.

• The efficacy and safety of the HDB regimen in STEMI has been evaluated in more than 20 clinical studies involving over 11,000 patients and is currently recommended by the ACCF/AHA Guideline for the Management of STEMI.On July 7, 2016, the Company received a Complete Response Letter (“CRL”) from the FDA for its sNDA requesting an expanded indication for patients presenting with STEMI.

• A Complete Response Letter indicates that the review cycle of the application is complete and the application will not be approved in its present form.

More Definitions of Complete Response Letter

Complete Response Letter means a written communication to an applicant from FDA usually describing all of the deficiencies that the agency has identi- fied in a biologics license application Food and Drug Administration, HHS § 600.11 or supplement that must be satisfac- torily addressed before it can be ap- proved.

Complete Response Letter. ’ means a written commu-

Complete Response Letter means a response from the FDA following acceptance by the FDA of the filing of an NDA for a particular Licensed Product indicating that the Regulatory Approval of such NDA is delayed or conditioned upon additional information becoming available or additional activities being performed for such Licensed Product.

Complete Response Letter means a complete response letter issued by the FDA in accordance with 21 C.F.R. §314.110.

Complete Response Letter means (a) a response from the FDA following the first acceptance by the FDA of the filing of the first NDA for a particular Product indicating that the Regulatory Approval of such NDA is delayed or conditioned upon additional information becoming available or additional activities being performed for such Product or (b) a response from the applicable Regulatory Authority following the first filing of an MAA for a particular Product (and, if applicable, acceptance of such filing by the applicable Regulatory Authority) that the Regulatory Approval of such MAA is delayed or conditioned upon additional information becoming available or additional activities being performed with respect to the Product.

Complete Response Letter or “CRL” means the BLA Complete Response Letter addressed by the FDA to Portola regarding Andexanet Alfa dated August 17, 2016.

Complete Response Letter means a letter from the FDA stating it will not approve the first application for a Health Registration Approval for the first Stand-Alone Product as contemplated by 21 C.F.R. §314.110.