NDA Acceptance means the written notification by the FDA that the NDA has met all the criteria for filing acceptance pursuant to 21 C.F.R.(S)314.101.
NDA Acceptance means the receipt of notice from the relevant Regulatory Authority that an NDA for the Covered Product has met all the criteria for filing acceptance.
NDA Acceptance means the written notification by the FDA or equivalent Governmental Authority in a foreign country that the NDA has met all the criteria for filing acceptance.
Examples of NDA Acceptance in a sentence
BMS will then pay an additional milestone of $ * to Flamel upon the earlier of: (x) BMS’ determination in its sole discretion that the long-term carcinogenicity studies are successful and will support an NDA filing in the U.S. or (y) upon NDA Acceptance in the U.S. *The asterisk denotes that confidential portions of this exhibit have been omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934.
Press Release dated February 25, 2014 entitled “BioCryst Announces Peramivir NDA Acceptance by the FDA” SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
More Definitions of NDA Acceptance
NDA Acceptance means acceptance for filing of an NDA by the applicable Competent Authority in the applicable jurisdiction.
NDA Acceptance means the written notification by the FDA that the NDA has met all the criteria for filing acceptance.
NDA Acceptance means the written notice of acceptance of a NDA sent by the FDA.
NDA Acceptance means, with respect to an NDA for a Product in the Field that has been submitted to the FDA by Shionogi or its Affiliate or Sublicensee, the date on which the applicant receives a notification from the FDA indicating that such NDA has been filed pursuant to 21 C.F.R. §314.101(a) or any equivalent or successor regulation.
NDA Acceptance means the earlier of (i) the date Cadence receives written notice from the FDA of acceptance by the FDA of an NDA filed by or on behalf of Cadence or its licensees with respect to any Product in the United States, or (ii) sixty (60) days following filing of such NDA with the FDA, provided that Cadence has not received a “Notice of Refusal to File” from the FDA with respect to such NDA.
NDA Acceptance means the earlier of: (i) receipt by GSK of written notice of acceptance from the FDA of an NDA filed by or on behalf of GSK under this Agreement necessary for Commercialization of Product in the United States, or (ii) sixty (60) days following filing of such an NDA with the FDA so long as GSK has not received a "Notice of Refusal to File" from the FDA with respect to such NDA.
NDA Acceptance means, with respect to each INDICATION, the earlier of (i) written notice of acceptance from the FDA of the NDA filed by or on behalf of SB under this AGREEMENT necessary for commercialization of PRODUCT for the relevant, whichever is appropriate, or (ii) sixty (60) days **=Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. following filing of such NDA with the FDA, assuming that SB has not received a "Notice of Refusal to File" from the FDA with respect to such NDA.