PDUFA definition
Examples of PDUFA in a sentence
At least [* * *] of Acceleron’s sales force planned to be available upon launch of the Licensed Product shall be hired no later than [* * *] before the PDUFA date, and Acceleron’s sales force shall be trained within [* * *] of hiring.
Orexigen submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave on March 31, 2010 and the Prescription Drug User Fee Act (PDUFA) action date has been set for January 31, 2011.
Each Party agrees to comply with all Applicable Laws, including, without limitation, GDUFA or PDUFA, cGMPs and state licensing laws, in its performance under this Agreement.
Each party agrees to comply with (and Eton shall ensure the compliance of CMO with) all Applicable Laws, including GDUFA or PDUFA, cGMPs and state licensing laws, in its performance under this Agreement.
In particular, Theravance shall be responsible for and pay all Prescription Drug User (PDUFA) annual establishment fees with respect to the Product.
If either IntelGenx or RedHill pay the PDUFA Fee as outlined in Section 4.3, the party paying the fees will file the application and act as the applicant during the regulatory review process.
Each Party agrees to comply with (and AN▇▇▇▇▇▇ ▇hall ensure the compliance of CMO with) all Applicable Laws, including, without limitation, GDUFA or PDUFA, cGMPs and state licensing laws, in its performance under this Agreement.
The FDA action date under the Prescription Drug User Fee Act (PDUFA) is October 23, 2012.
Sintetica will be responsible for payment of the NDA filing fees (i.e., the PDUFA fee for FDA).
For the avoidance of doubt, TRIS shall be responsible for payment of all fees payable with regard to CCP-08 up to and including Regulatory Approval, including the NDA submission PDUFA fee for CCP-08, but excluding any PDUFA Program Fee assessed upon approval.