Pre-BLA Meeting definition

Pre-BLA Meeting means a meeting with FDA, the primary purpose of which is to uncover any major unresolved problems, to identify those studies that the sponsor is relying on as adequate and well-controlled to establish the drug’s effectiveness, to identify the status of ongoing or needed studies adequate to assess pediatric safety and effectiveness, to acquaint FDA reviewers with the general information to be submitted in the marketing application (including technical information), to discuss appropriate methods for statistical analysis of the data, and to discuss the best approach to the presentation and formatting of data in the marketing application, as further defined in 21 C.F.R. 312.47(b)(2), as amended from time to time, or the corresponding foreign equivalent.
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Examples of Pre-BLA Meeting in a sentence

  • Previous COA Reviews:(b) (4)• IND 114647 - Eptinezumab formigraine (b) (4) in adult patients: Type B Pre-BLA Meeting (Susan Pretko; dated April 16, 2019) Background:(b) (4)• COA Staff have previously commented on the The Sponsor stated that theywould submit additional evidence with their BLA package.

  • The Agency accepted Keytrudaon October 3, 2014.- October 25, 2013: The Agency held at Pre-BLA Meeting with the applicant and reached agreement for the proposed content of Original BLA 125-514.

  • The Merger Agreement provides that, following completion of the Offer and on the terms and conditions of the Merger Agreement, and in accordance with the DGCL, at the Effective Time, Purchaser will merge with and into Dermira, and the separate existence of Purchaser will cease, and Xxxxxxx will continue as the Surviving Corporation.

  • WBS 2.5.2.2 Pre-BLA Meeting Objective/Description of Work: Prior to BLA submission, MediWound plans a pre-BLA meeting with the FDA.

  • An early filing strategy was proposed and agreed to by FDA at a Pre-BLA Meeting.

  • Outlook Cash runway into 2020, with no outstanding debt March 31, 2019 March 31, 2018 Cash and Cash $42.4M $19.7M Equivalents Important upcoming milestones with FDA* Type of FDA Meeting Confirmed Meeting Date Type C CMC Meeting May 20, 2019 Type B Pre-BLA Meeting June 6, 2019 *Note: Timing and content of public disclosures regarding meeting outcomes may depend on the receipt of the official FDA meeting minutes, which can take approximately 30 days post meeting.

Related to Pre-BLA 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.

  • 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;

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

  • Shareholders Meeting has the meaning provided in Section 6.3.

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

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

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

  • 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.

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

  • 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;

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

  • 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.

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

  • Meeting means any meeting of:

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

  • Board Meeting means a meeting of the Board;

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

  • 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;

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

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

  • Company Shareholders Meeting shall have the meaning set forth in Section 2 hereof.

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

  • 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)

  • Company Stockholders Meeting has the meaning set forth in Section 6.2(a).

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

  • 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;