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 5.1(c).
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FDA Meeting means an end of phase 2 meeting to be held between Buyer and the FDA to discuss the development of the Compound.
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Examples of FDA Meeting in a sentence

  • Promptly following the Initial FDA Meeting, Vernalis shall transfer the MAM Product IND to Endo free from any Encumbrance.

  • Accordingly, Purchaser accepts any and all risks of Losses associated with any change of the FDA’s position from that set forth at the FDA Meeting regarding the manufacture of the Product.

  • Purchaser acknowledges that the FDA has not approved or issued minutes of the FDA Meeting documenting the FDA’s consent to manufacture in the manner set forth at the FDA Meeting, and Purchaser accepts any risk associated therewith.

  • The Company shall provide Buyer with a copy of the final minutes for the FDA Meeting (the “FDA Minutes”) within two (2) Business Days following the Company’s receipt of the FDA Minutes from the FDA.

  • Buyer’s Representatives shall be allowed to participate in the FDA Meeting.

  • Senetek may appoint a representative to attend the FDA Meeting at the cost and expense of Senetek.

  • Promptly following the FDA Meeting the Company will report the outcome of the FDA Meeting to the Purchasers orally and will issue a press release concerning the meeting.

  • Accordingly, Purchaser accepts any and all risks of Losses associated with any change of the FDA's position from that set forth at the FDA Meeting regarding the manufacture of the Product.

  • FDA Meeting Memo (pre-approval request): Biophausia requested NDA meeting “Drug for Debridement” to proceed directly to NDA.

  • Medgenics will disclose to KHK any and all material correspondence between Medgenics and the FDA regarding the Initial Development, including without limitation any information discussed with the FDA in the FDA Meeting (as defined in Section 2.5.2) and FDA minutes concerning the Initial Development, within ***** after receipt or transmission thereof.


More Definitions of FDA Meeting

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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Related to FDA Meeting

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

  • Council Meeting means a meeting of Council;

  • 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.