FDA Submission definition

FDA Submission filing for FDA Approval.
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FDA Submission means submission of a dossier on the Device to the United States Food and Drug Administration (“FDA”) for permission to market and sell the Device in the United States of America.
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FDA Submission means a submission to the FDA, with respect to any Principal Product, of a premarket approval application (PMAA) which, if submitted prior to the Closing Date, the Company has delivered to Parent for Parent’s review at least thirty (30) calendar days prior to its submission.
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Examples of FDA Submission in a sentence

  • Baxter agrees to notify the United States Food and Drug Administration (FDA) by way of a written notice, on which Buyer is copied, that Baxter is authorizing Buyer to reference the data within the Tisseel Biologics License Application, FDA Submission Tracking Number (the “Tisseel Specifications”), as well as European regulatory authorities and other authority as needed.

  • Upon completion of both Phases 3 and 4 described in the FDA Submission Plan, ▇▇▇▇▇▇ shall pay to HDC a one-time Phase 3 and 4 Completion Milestone Fee of Two-Hundred-Fifty-Thousand U.S. Dollars ($250,000.00).

  • In this event, any such writing will modify the FDA Submission Plan to establish each party’s responsibilities and whether any additional time or funding is required.

  • During the Collaboration Term, HDC will provide materials (“HDC Materials”), including, without limitation, test reagent samples and clinical samples, to ▇▇▇▇▇▇, and ▇▇▇▇▇▇ will provide materials, including, without limitation, test reagents and clinical samples necessary to complete the Collaboration (collectively, “▇▇▇▇▇▇ Materials”) to HDC for the purposes described in the FDA Submission Plan.

  • During the Collaboration Term and pursuant to the FDA Submission Plan, ▇▇▇▇▇▇ and HDC agree to collaborate on the performance of the necessary validation studies and clinical trial(s), and the preparation of and submission to the U.S. Food and Drug Administration (“FDA’) of either a 510(k) or PMA application seeking the necessary authorization from the FDA for the U.S. marketing, use and sale with associated claims of medical utility of a prostate cancer diagnostic assay (the “Collaboration”).

  • In connection with preparation by Animas of the FDA Submission and during the review by FDA of the FDA Submission, Debiotech shall: a) furnish all test results and documentation on MEMS Micro-Needle required by FDA and, b) remain available for responding to questions by FDA relating to such FDA Submission.

  • Promptly after the filing by ▇▇▇▇▇▇ with the FDA of either a 510(k) or PMA submission, ▇▇▇▇▇▇ shall pay to HDC a one-time FDA Submission Fee of Five-Hundred-Thousand U.S. Dollars ($500,000.00).

  • Any new invention, development or discovery relating to the Field or New Prostate Markers for the Field conceived, made or reduced to practice by either party as part of the Collaboration, the FDA Submission Plan or with the use of Materials of the other party (each a “New Invention”) shall be promptly disclosed in writing to the other party.

  • Following the Closing, the Principal Shareholders and the Buying Parties, together, shall establish an anticipated budget for such upcoming year that designates the anticipated funds and resources that will enable the Business to efficiently accomplish an FDA Submission and FDA Clearance.

  • If Animas decides to perform clinical trials prior to FDA Submission, the Additional License Fee shall be Two Million Dollars ($2,000,000) and shall be paid within 30 days after Debiotech provides Animas with FDA Deliverables, irrespective of the deadlines above.

Related to FDA Submission

  • Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • Regulatory Filing means any documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to any compound or product (including any Licensed Compound or Licensed Product), or its use or potential use in humans, including any documents submitted to any Regulatory Authority and all supporting data, including INDs and NDAs, and all correspondence with any Regulatory Authority with respect to such compound or product (including minutes of any meetings, telephone conferences or discussions with any Regulatory Authority).

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.