FDA Acceptance definition

FDA Acceptance means the FDA’s acceptance for review of the Borrower’s NDA for KP201 for the treatment of acute pain in humans, provided that such NDA conforms, in the reasonable determination of the DPDF Lender, to FDA’s requirements for approval as informed by the advice and guidance provided to the Borrower by the FDA.
Sample 1Sample 2Sample 3
FDA Acceptance means the date on which FDA notifies AstraZeneca that the application for a Health Registration Approval for the first Stand-Alone Product is accepted for review by the FDA.
Sample 1

Examples of FDA Acceptance in a sentence

  • Zogenix Announces U.S. FDA Acceptance for Priority Review of Supplemental New Drug Application for FINTEPLA® (Fenfluramine) for the Treatment of Seizures Associated with Lennox-Gastaut Syndrome (LGS).

  • USL shall be responsible for diligently compiling the Product NDA in accordance with the Development Plan, and for having it filed with the FDA within five (5) months after USL’s receipt of all data, information and documents (including without limitation, all analyses and re-analyses) necessary or beneficial to prepare such filing, and for obtaining FDA Acceptance of the Product NDA.

  • Finally, FDA promotes the advancement of regulatory science by authoring FDA and international guidances, conducting and 5 For more information on the use of information relating to foreign clinical trials in INDs and applications for marketing approval submitted to FDA, see the guidance for industry and FDA staff FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions.

  • Antares issued a press release entitled “Antares Pharma Announces FDA Acceptance of New Drug Application for QuickShot Testosterone.” In the press release, the Company stated, in part: The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of October 20, 2017, ten months from the official NDA submission.

  • USL shall pay to Orion a first milestone payment of US Dollars [***] (the “First Milestone Payment”) for previously completed research, formulation and clinical development, payable within thirty (30) days after the later of (a) USL’s receipt of notification of FDA Acceptance of the Product NDA, accompanied by a copy of such FDA Acceptance, if any, and (b) USL’s receipt of Orion’s invoice for such First Milestone Payment.

  • Finally, the estimated size of the patient population likely to use Tyvaso DPI includes not just PAH and PH-ILD patients, but also patients with other forms of PH categorized as WHO 27 UTC Press Release, United Therapeutics Announces FDA Acceptance of Tyvaso DPI™ New Drug Application for Priority Review (June 16, 2021) (Exhibit 3).

  • Spero issued a press release entitled “Spero Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Tebipenem HBr for the Treatment of Complicated Urinary Tract Infections including Pyelonephritis.” The press release stated, in relevant part: Spero [.

  • USL shall pay to Orion a first milestone payment of US Dollars five hundred thousand ($500,000) (the “First Milestone Payment”) for previously completed research, formulation and clinical development, payable within thirty (30) days after the later of (a) USL’s receipt of notification of FDA Acceptance of the Product NDA, accompanied by a copy of such FDA Acceptance, if any, and (b) USL’s receipt of Orion’s invoice for such First Milestone Payment.

  • SEEKING ALPHA, LANNETT (LCI) Q1 2019 RESULTS - EARNINGS CALL TRANSCRIPT at 3 (Nov.7, 2018) [Exhibit 4]; see also Press Release, Lannett Co., Lannett Announces FDA Acceptance of 505(b)(2) New Drug Application for Cocaine Hydrochloride Topical Solution, a Proprietary Anesthetic Product (Dec.

  • VIVUS Reports 2006 Fourth Quarter and Full-Year Financial ResultsPositive Phase 2 Data for Qnexa and FDA Acceptance of EvaMist NDA Submission Lead 2006 HighlightsMOUNTAIN VIEW, Calif., March 2, 2007 — VIVUS, Inc.

Related to FDA Acceptance

  • XXXX Acceptance Form means the “Acceptance Form for End User License Agreement (for SAP On Premise indirect sales)” which will be provided by SAP on a deal by deal basis.

  • Final completion and acceptance means the stage in the progress of the work as determined by the Contracting Officer and confirmed in writing to the Contractor, at which all work required under the contract has been completed in a satisfactory manner, subject to the discovery of defects after final completion, and except for items specifically excluded in the notice of final acceptance.

  • Date of Acceptance means the date, which appears on the Notice of Acceptance and if no date appears is the date on which the Principal sent the Notice of Acceptance accepting the Contractor’s Tender.

  • Notice of Acceptance means the written notification and any accompanying documentation sent to the Consultant by the Principal advising acceptance of its Tender to provide the Services under the Contract.

  • Conditional Acceptance means a conditional acceptance by the Liquidity Provider of an extension of the Scheduled Termination Date.

  • Letter of Acceptance (LOA) means the written notice issued by JMRC to the selected bidder(s) intimating the acceptance of selected bidder's Proposal for the award of License;

  • Letter of Acceptance means the letter of formal acceptance, signed by the contractor. Procuring Entity, including any annexed memoranda comprising agreements between and signed by both Parties.

  • Final Acceptance means final written acceptance of all the Work by the Commissioner, a copy of which shall be sent to the Contractor.

  • Operational Acceptance means the acceptance by the Procuring Entity of the Facilities (or any part of the Facilities where the Contract provides for acceptance of the Facilities in parts), which certifies the Contractor's fulfillment of the Contract in respect of Functional Guarantees of the Facilities (or the relevant part thereof) in accordance with the provisions of GCC Clause 28 (Functional Guarantees) hereof and shall include deemed acceptance in accordance with GCC Clause 25 (Commissioning and Operational Acceptance) hereof.

  • Confirmation of Acceptance shall have the meaning specified in paragraph 2B(5).

  • Competitive Bid Accept/Reject Letter means a notification made by the Borrower pursuant to Section 2.03(d) in the form of Exhibit A-4.

  • Commitment and Acceptance is defined in Section 2.18(b).

  • Acceptance Letter means the letter from Adviser to BD pursuant to which the Adviser appoints BD as a Broker Dealer for each series of MuniPreferred issued by any Fund that has executed a Request Letter.

  • Letter of Acceptance of Tender means letter giving intimation to the tenderer that his tender has been accepted in accordance with the provisions contained in that letter.

  • IITK Purchase Order means the IITK’s official Purchase Order document;

  • Commercial use request means a re- quest from or on behalf of one who seeks information for a use or purpose that furthers the commercial, trade, or profit interests of the requester or the person on whose behalf the request is made.

  • Acceptance Test is a test of the Features executed by the Customer to prepare the acceptance.

  • Certificate of Acceptance means written certification, delivered to Contractor and signed by an authorized representative of the State, stating that any Defects in a particular Phase or the Solution discovered after implementation and testing have been corrected as required under this Contract, and that the Phase complies in all material respects with all of the applicable Requirements.

  • Acceptance Day shall have the meaning specified in paragraph 2B(5).

  • Final Acceptance Date means, in respect of any Offer, the final date for acceptance of such Offer which, if such Offer is extended prior to becoming unconditional, shall be the final date for acceptance of the extended Offer (but, if such Offer is or becomes unconditional, disregarding any additional or further period during which such Offer is open for acceptance);

  • Non-Extension Drawing has the meaning specified in Section 3.5(d).

  • Non-Acceptance of Proposal means another proposal was deemed more advantageous to the University or that all proposals were rejected.

  • Acceptance Tests means those tests performed during the Performance Period which are intended to determine compliance of Equipment and Software with the specifications and all other Attachments incorporated herein by reference and to determine the reliability of the Equipment.

  • Acceptance Testing mean the tests, reviews and other activities that are performed by or on behalf of Agency to determine whether the Deliverables meet the Acceptance Criteria or otherwise satisfy the Agency, as determined by the Agency in its sole discretion.

  • Form of Acceptance means the Form of formal acceptance, signed by the Procuring Entity, of the Form of Tender, including any annexed memoranda comprising agreements between and signed by both Parties. If there is no such Form of acceptance, the expression “Form of Acceptance” means the Contract Agreement and the date of issuing or receiving the Form of Acceptance means the date of signing the Contract Agreement.

  • Acceptance of Bid means the letter/fax or any memorandum communicating to the Bidder the acceptance of its Bid and includes an advance acceptance of his Bid.