PDUFA definition

PDUFA means Prescription Drug User Fee Act.
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PDUFA means the US Prescription Drug User Fee Act of 1992, as amended.
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PDUFA means the Prescription Drug User Fee Act, as amended and supplemented and as the same may be further amended and supplemented, and rules and regulations of the FDA promulgated thereunder.
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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.


More Definitions of PDUFA

PDUFA means Prescription Drug User Fee Act, which allows the FDA to collect fees from drug manufacturers to fund the drug approval process.
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PDUFA means the Prescription Drug User Fee Act (as may be amended from time to time).
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PDUFA has the meaning set forth in Section 6.2 hereof.
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PDUFA means the U.S. Prescription Drug User Fee Act.
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PDUFA has the meaning set forth in Section 3.1.1.
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Related to PDUFA

  • Fee Application means an application filed with the Bankruptcy Court in accordance with the Bankruptcy Code and Bankruptcy Rules for payment of a Professional Claim.

  • Cost of Goods Sold means [***].

  • PMDA means Japan’s Pharmaceuticals and Medical Devices Agency or any successor entity thereto.

  • Manufacturing Costs means, with respect to a given AquaBounty Product, the full-time equivalent costs (under a reasonable accounting mechanism to be agreed upon by the Parties) and out-of-pocket costs that AquaBounty or any of its Affiliates incurred in manufacturing such products, including costs and expenses incurred in connection with (a) the development or validation of any manufacturing process, formulations or delivery systems, or improvements to the foregoing; (b) manufacturing scale-up; (c) in-process testing, stability testing and release testing; (d) quality assurance/quality control development; (e) internal and Third Party costs and expenses incurred in connection with qualification and validation of Third Party contract manufacturers, including scale up, process and equipment validation, and initial manufacturing licenses, approvals and inspections; (f) packaging development and final packaging and labeling; (g) shipping configurations and shipping studies; and (h) overseeing the conduct of any of the foregoing. “Manufacturing Costs” shall further include: (i) to the extent that any such AquaBounty Product is manufactured by a Third Party manufacturer, the out-of-pocket costs incurred by AquaBounty or any of its Affiliates to the Third Party for the manufacture and supply (including packaging and labeling) thereof, and any reasonable out-of-pocket costs and direct labor costs incurred by AquaBounty or any of its Affiliates in managing or overseeing the Third Party relationship determined in accordance with the books and records of such Party or its Affiliates maintained in accordance with US GAAP; and (ii) to the extent that any such AquaBounty Product is manufactured by AquaBounty or any of its Affiliates, direct material and direct labor costs attributable to such product, as well as reasonably allocable overhead expenses, determined in accordance with the books and records of AquaBounty or its Affiliates maintained in accordance with US GAAP.

  • 340B drug means a drug purchased through the 340B drug discount program by a 340B entity.