NDA Approval definition
NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.
NDA Approval means the receipt of notice from the relevant US Regulatory Authority that an NDA for a Licensed Product has met all the criteria for marketing approval.
NDA Approval means the Approval of an NDA by the FDA for the applicable Product in the U.S.
Examples of NDA Approval in a sentence
As between the Parties, Client is solely responsible for and owns all right, title and interest in and to (a) all Regulatory Documentation concerning the Product and all information contained therein, (b) all regulatory approvals made or granted with respect to the Product, including any NDA Approval, and (c) all final Promotional Materials approved for use by Client pursuant to Section 3.4c.
As between the Parties, Client has the sole right and responsibility for obtaining and maintaining all regulatory approvals for the Product in the Territory, including NDA Approval for the Product and for complying with all regulatory reporting obligations with respect to the Product in the Territory.
More Definitions of NDA Approval
NDA Approval means approval by the FDA for marketing and sale of a Product in the United States, including any applicable pricing, final labeling or reimbursement approvals, as applicable.
NDA Approval means written approval by the FDA of an NDA pursuant to 21 C.F.R. § 314.105 for a Milestone Product and satisfaction of related applicable FDA requirements, if any, and any conditions of approval set forth in such writing.
NDA Approval means the approval by the competent registration body for a given country of an NDA.
NDA Approval means an NDA approved by the FDA or EMEA that is not conditioned on any other event (or if NDA Approval is conditioned upon an event, then the occurrence of that event), provided, however, such other events shall specifically not include FDA or EMEA requirements to conduct post marketing studies and any requirement for such post marketing studies shall not be deemed to delay the Final Approval.
NDA Approval means the final approval to market the Product by the FDA as defined under the Act.
NDA Approval means approval by the FDA for marketing and sale of a Licensed Product in the United States.
NDA Approval means approval of the NDA for the Product filed in the Territory, including pricing or reimbursement, where applicable, by the Regulatory Authority in the Territory.