End of Phase 2 Meeting definition

End of Phase 2 Meeting means the first end of Phase 2 meeting with the FDA, as defined in 21 CFR Section 312.47, intended to determine the safety of proceeding to Phase 3, evaluate the Phase 3 plan and protocols and identify any additional information necessary to support an NDA for Product.
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End of Phase 2 Meeting means a meeting with FDA, the purpose of which is to determine the safety of initiating a first Phase III Clinical Study, to evaluate the Phase III Clinical Study plan and protocols and the adequacy of current studies and plans to assess pediatric safety and effectiveness, and to identify any additional information necessary to support a Drug Approval Application for the uses under investigation, as further defined in 21 C.F.R. 312.47(b)(1), as amended from time to time, or the corresponding foreign equivalent.
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End of Phase 2 Meeting means the end-of-Phase 2 meeting with FDA as described in 21 CFR 312.47(b).
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Examples of End of Phase 2 Meeting in a sentence

  • For clarity, AbbVie shall lead the End of Phase 2 Meeting with the FDA for each Product or seek “Scientific Advice” from the EMA with respect to each Product.

  • End of Phase 2 Meeting —in which sponsors seek FDA input on their Phase 3 clinical studies that are generally pivotal to FDA application review and market approval.

  • Following the last Phase 2 Clinical Trial for Type 2 diabetes, as determined by the JDC, XOMA agrees to schedule and attend an End of Phase 2 Meeting with the FDA with respect to the anticipated Phase 3 clinical program for Type 2 diabetes, should the data warrant.

  • In June 2021, the Company paid a $10,000 milestone payment to Enteris based on a successful End of Phase 2 Meeting with the FDA in April 2021, which was recorded in R&D expense for the nine months ended September 30, 2021.

  • For clarity, the submission by Targacept of documents, questions or other information or materials to, or other communication with, the FDA in contemplation of an End of Phase 2 Meeting to be conducted after the earlier of the Effective Date or ********, 2010 is expressly permitted and shall not be deemed to violate or breach this Section 12.19.1 or any other provision of this Agreement.

  • We are pleased to report that at the end of 2018, Neuren stands in an immeasurably stronger position than some 14 months ago prior to our End of Phase 2 Meeting with the US Food and Drug Administration (FDA).

  • CDER Clinical Review Template 10Version date: September 6, 2017 for all NDAs and BLAs The following meetings were conducted under IND 122483 for this application:• End of Phase 2 Meeting Minutes 11/30/18• End of Phase 2 Response to PRO Information Request 11/21/18• Pre-NDA Meeting 12/11/19• Type C Meeting 7/21/203.3. Foreign Regulatory Actions and Marketing HistoryPilocarpine is not approved in any country for presbyopia.

  • The Company has completed the End of Phase 2 Meeting with US Food and Drug Administration (FDA) in January 2017, and has received thewritten reply from Europe EMA regarding the questions related to the Company's subsequent design of global phase III clinical trial for OBI-822.

  • Except as provided in subsection H (below), retirees shall not make any contribution toward healthcare insurance provided through this Agreement.

  • WBS 3.5 Regulatory WBS 3.5.1 IND WBS 3.5.1.1 Reserved WBS 3.5.1.2 Reserved WBS 3.5.1.3 Reserved WBS 3.5.1.4 End of Phase 2 Meeting Conduct EOP2 meeting with FDA.


More Definitions of End of Phase 2 Meeting

End of Phase 2 Meeting means any “End-of-Phase 2 Meeting” as described in 21 CFR 312.47, or, with respect to the EU, a similar meeting with the EMA.
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End of Phase 2 Meeting means the receipt by Somaxon of the FDA's minutes from the meeting to be held between Somaxon and the FDA to discuss the results of the Phase 2 Clinical Trials.
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End of Phase 2 Meeting means the end of Phase 2 meeting with the FDA, as described in 21 C.F.R. § 312.47(b), intended to determine the safety of proceeding to Phase 3, to evaluate
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End of Phase 2 Meeting means the first end of Phase 2 meeting with the FDA, as defined in 21 CFR Section 312.47, intended to determine the safety of proceeding to Phase 3, evaluate the Phase 3
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End of Phase 2 Meeting means any meeting with the FDA for the purpose of (a) reviewing data from a Phase 2 Clinical Trial for a Licensed Product or (b) discussing the design of a pivotal Phase 3 Clinical Trial for a Licensed Product.
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End of Phase 2 Meeting means the first end of Phase 2 meeting with the FDA, as defined in 21 CFR Section 312.47, intended to determine the safety of proceeding to ** CERTAIN INFORMATION (INDICATED BY ASTERISKS) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. AN UNREDACTED VERSION OF THIS DOCUMENT HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. Phase 3, evaluate the Phase 3 plan and protocols and identify any additional information necessary to support an NDA for Product.
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Related to End of Phase 2 Meeting

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

  • General Meeting means the annual or any special general meeting of the Association.

  • 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;

  • Board Meeting means a meeting of the Board;

  • 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.

  • JRC has the meaning set forth in Section 2.2.

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

  • 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;

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

  • JMC has the meaning set forth in Section 3.2(a).

  • JDC has the meaning set forth in Section 3.2.

  • JSC has the meaning set forth in Section 3.1.

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

  • Shareholders Meeting has the meaning provided in Section 6.3.

  • Annual Meeting means the annual meeting of the stockholders of the Company.

  • Annual General Meeting means the meeting held by the Society in the first four months (or such other period as permitted by the Statutes) of each Financial Year at which the Annual Accounts are presented and which is specified as such in the notice convening the meeting;

  • 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.

  • 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;

  • 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.

  • Meeting of Members means an annual meeting of members or a special meeting of members;

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • 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.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

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

  • Shareholder Meeting means an annual general meeting of shareholders or special meeting of shareholders of the Company called for the purpose of electing directors to the board of directors of the Company.

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