FDA Meeting definition

FDA Meeting means the February 7, 2001 meeting between representatives of the FDA, Seller and Purchaser.
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FDA Meeting has the meaning set forth in Section 5.11(c).
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FDA Meeting means a meeting between EIP or any of its Affiliates and the FDA for the purpose of discussing, and gaining FDA’s agreement on, the size, design and endpoints of a Phase 2 Clinical Trial of Licensed Product.
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Examples of FDA Meeting in a sentence

  • FDA Meeting Notification No later than 10 business days prior to the scheduled meeting The contractor shall forward the dates and times of any meeting with the FDA to BARDA and arrange for appropriate BARDA staff to attend the FDA meetings.

  • FDA Meeting of the Tobacco Products Scientific Advisory Committee.

  • To facilitate CIRM’s participation in such meetings, Awardee shall notify CIRM as soon as practicable after it has scheduled an FDA meeting and provide to CIRM any data package(s) or other information, including confidential and/or proprietary information, prior to submission to the FDA as well as any FDA Meeting minutes.

  • Therefore, this particular FDA communication concerning CARDINAL’s design and washout period adequacy must have been made no later than in the January 2020 FDA Meeting.

  • Reata’s intent in the January 2020 FDA Meeting was to propose a quick NDA filing for FDA accelerated approval, based on the CARDINAL year-one eGFR data.

  • Meeting adjoured with no other business to discuss MAIL ORDER COMMITTEE CALL OCTOBER 25, 12:00 EST Present VOTING MEMBERS: Applewhite, Reyes, Auffray, Harris, Marlow, Schaffner, Thomas, Caballero, Zimmerman, WeddigPresent At-large Members: Lee, Manuel, MoretzPresent Federal Consultants: Abley (USDA), Otto (FDA) Meeting called to order by Chair Applewhite Discussion:1) Committee was reminded of CFP Anti-trust statement2) John Zimmerman made a motion to accept the minutes of the 10/11/16 call.

  • Immediately following the January 2020 FDA Meeting, the tone and content of the Reata Defendants’ public disclosures concerning FDA matters shifted notably.

  • And in August 2020, when the Reata Defendants resumed commentary on FDA-related matters, they still omitted to disclose any of the sharp substantive differences between Reata and the FDA that had surfaced in the January 2020 FDA Meeting, and instead mischaracterized FDA-Reata debates as primarily procedural ones, concerning merely the timing rather than the substance of a Bard NDA filing.

  • Onsite registration on the day of the hearing will be based on space availability.FDA will provide additionalbackground information at the time the Federal Register notice is published and an agenda approximately 2 weeks before the hearing at FDA Meeting Information page, which is available online at http:// www.fda.gov/Drugs/NewsEvents/ ucm398454.htm.Time will be reserved during thehearing for planned presentations from the audience.

  • The initial Development Plan shall be as set forth in Exhibit 2 hereto and shall (a) cover Phase II Development up to and including the End of Phase IIA FDA Meeting and any immediate follow-up Phase II Development activities directly resulting from such meeting and (b) a non-binding, high level projection of the Phase II Development activities to be undertaken thereafter.

Related to FDA Meeting

  • Open meeting or "public meeting" means a meeting at which the public may be present.

  • Court Meeting means the meeting(s) of the Scheme Shareholders to be convened by order of the Court pursuant to section 896 of the Companies Act, notice of which will be set out in the Scheme Document, for the purpose of approving the Scheme, including any adjournment thereof;

  • relevant meeting means a meeting of the authority to consider whether or not to approve a proposal to dismiss a relevant officer; and

  • Company Meeting means the special meeting of Company Shareholders, including any adjournment or postponement of such special meeting in accordance with the terms of the Arrangement Agreement, to be called and held in accordance with the Interim Order to consider the Arrangement Resolution.

  • Public meeting means a meeting that is required to be open to the public under Title 52, Chapter 4, Open and Public Meetings Act.

  • Members meeting means an annual members meeting or special meeting of members.

  • Shareholder Meeting means a meeting of the Company’s shareholders.

  • Meeting means any meeting of:

  • Scoping meeting means a meeting between representatives of the applicant and the EDU conducted for but not limited to the following purposes:

  • Shareholders Meeting has the meaning provided in Section 6.3.

  • meeting of shareholders means an annual meeting of shareholders or a special meeting of shareholders;

  • Special Meeting shall have the meaning set forth in Section 23(c)(i) hereof.

  • Scheme Meeting means the meeting of Shareholders ordered by the Court to be convened pursuant to the Initial Orders in respect of the Scheme and includes any adjournment of that meeting.

  • Review Meeting means a meeting to be held in accordance with clause B19 (Review Meetings) or as otherwise requested in accordance with clause B19.2 (Review Meetings)

  • hybrid meeting means a general meeting convened for the (i) physical attendance by shareholders and/or proxies at the Principal Meeting Place and where applicable, one or more Meeting Locations and (ii) virtual attendance and participation by shareholders and/or proxies by means of electronic facilities;

  • Board Meeting means a meeting of the Board;

  • Stockholder Meeting means each annual or special meeting of stockholders of the Company, or any action by written consent of the Company’s stockholders in lieu thereof, and any adjournment, postponement, rescheduling, continuation or meeting held in lieu thereof;

  • Virtual Meeting means any general meeting of the Shareholders (or any meeting of the holders of any Class of Shares) at which the Shareholders (and any other permitted participants of such meeting, including without limitation the chairman of the meeting and any Directors) are permitted to attend and participate solely by means of Communication Facilities.

  • special meeting of shareholders means a meeting of any particular class or classes of shareholders and a meeting of all shareholders entitled to vote at any annual meeting of shareholders at which special business is to be transacted.

  • Kick Off Meeting means a meeting convened by the Purchaser to discuss and finalize the work execution plan and procedures with the ITC.

  • ordinary meeting means a meeting held by determination of the Board (SER r.115(1)).

  • physical meeting means a general meeting held and conducted by physical attendance and participation by shareholders and/or proxies at the Principal Meeting Place and/or where applicable, one or more Meeting Locations;

  • Stockholders Meeting shall have the meaning set forth in Section 6.2(c).

  • special meeting in lieu of an annual meeting means a special meeting called by Directors for the purpose of electing Directors in the event that an annual meeting is not held on or before such date as may be required by the NYSE Amex, New York Stock Exchange or such other exchange or trading system on which shares are principally traded, if applicable.

  • Pre-bid Meeting means Pre-bid meeting to be held as per the schedule indicated in the Schedule for the Tender hereof;

  • Meeting of Members means an Annual Meeting of Members or a Special Meeting of Members.