NDA Submission definition

NDA Submission means the submission of an NDA to the applicable Regulatory Authority: (a) in the U.S., (b) as a centralized filing with the EMEA, or (c) in Japan, as applicable; provided in each case that such submission shall be deemed to have occurred when all required components of the NDA have been filed with the Regulatory Authority by (or on behalf of) the filing party.
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NDA Submission means the first submission by or on behalf of ViaCell or its Affiliates to the applicable Regulatory Agency of a Major Market of a completed application for Product Approval of the use of the applicable Product in the Field in that Major Market.
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NDA Submission means the submission of an NDA to the CFDA (or any equivalent agency or Regulatory Authority in the Territory) in writing.
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Examples of NDA Submission in a sentence

  • NDA Submission and Review by the FDAAssuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development, nonclinical studies and clinical trials are submitted to the FDA as part of a NDA requesting approval to market the product for one or more indications.

  • Following its receipt of the NDA Submission Notice, DICERNA shall have the right, upon written notice, to review all Drug Approval Applications prepared for such Licensed Product for the Initial Target, including the NDA, and all correspondence submitted or received with respect to such Licensed Product, at DICERNA’s sole cost and expense.

  • KHK shall give DICERNA written notice of its intent to submit an NDA to the FDA with respect to each Licensed Product for the Initial Target at least [***] prior to the anticipated date of such submission (each, an “NDA Submission Notice”), which NDA Submission Notice shall include a written report setting forth in reasonable detail all Development Costs incurred by KHK with respect to such Licensed Product through the date of the NDA Submission Notice.

  • If ViaCell proceeds to NDA Submission without having made the Milestone Payment for milestone "a" (Commencement of Phase III Clinical Trial), e.g., because the data from a Phase II clinical trial is believed to be sufficient for registration, then such Milestone Payment for milestone "a" shall be made concurrently with the Milestone Payment for Milestone "b" (NDA Submission).

  • We began our commercial launch of XYDALBA in the United Kingdom and Germany in the fourth quarter of 2016 and in France in the first quarter of 2017.SteadyMed’s NDA Submission of TREVYENTOn July 3, 2017, SteadyMed submitted a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for TREVYENT.

  • Total Time for Completion of CMC section for NDA: 4-8 wks Development Costs (per product): $ [***] (upon commencement of Stage III) * Validation of manufacturing processes will be performed after NDA Submission and prior to Product Launch.

  • Toshiyuki IkeuchiCorporate CommunicationsTakeda Pharmaceutical Company Limited+1 81-3-3278-2037Josephine ZammutoCorporate CommunicationsTakeda Global Research & Development Center, Inc., U.S.224-554-2795 AFFYMAX AND TAKEDA CONFIRM U.S. REGISTRATION STRATEGY FOR INVESTIGATIONAL DRUG, HEMATIDE™/PEGINESATIDE, FOLLOWING MEETING WITH FDA- Companies Confirm Q2 2011 Timeline for NDA Submission —PALO ALTO, Calif., and OSAKA, Japan, Nov 29, 2010 — Affymax, Inc.

  • OPEX Guidance* $660-755M includes regulatory milestones up to $65M 2024 Total Revenue Guidance $600-$850M PTC Therapeutics – JP Morgan 2024 Key Expected Regulatory & Clinical Milestones in 2024 13 Q1 Q2 Q3 Q4 Sepiapterin PKU MAA Submission Sepiapterin PKU NDA Submission Upstaza BLA Submission t Topline Results Utreloxastat Interim Results PTC518 PTC Therapeutics – JP Morgan 2024 Sepiapterin PKU Program Patient Living with PKU 15 PTC Therapeutics – JP Morgan 2024 Phe, phenylalanine; PKU, phenylketonuria.

  • Milestone Event Milestone Payment Upon NDA Submission [****] US NDA Approval [****] EU MAA Approval [****] Notable shall inform Oxxxxxxxxx in writing on the occurrence of a milestone event under this Section 7.3 as soon as possible, but in no event later than thirty (30) days after the occurrence thereof.

  • Start of a Pivotal Trial in the U.S. $6.3 MM NDA Submission to FDA $12.6 MM NDA Approval by FDA $23.1 MM ------------------- -------- Total $42.0 MM Category Three Indications - If a Category Three indication is the first indication for a Licensed Product, the Category Three Milestones will be paid in the amounts set forth below upon the first occurrence of the events set forth below.


More Definitions of NDA Submission

NDA Submission means the submission of Technical Information, and other materials for review by the relevant governmental or regulatory authorities for evaluation for possible NDA Approval.
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NDA Submission means notification from the FDA indicating acceptance for the filing of the NDA in the United States for the Product for use in the Indication. (ooo) "Net Sales" means collectively, the gross amount invoiced by Fujisawa or its Affiliates or by sublicensees granted a sublicense pursuant to Section 3.7(b) for sales of the Product in the Field to a Third Party for use in the Territory (other than sales of Products by Sublicensees in Mexico), less the following as they pertain to the Product: (i) any and all normal and customary trade and quantity discounts and customary allowances actually granted to purchasers of a Product for returns or credits, recalls (whether in the form of a credit or free replacement actually given in place of a returned or recalled Product), allowances to end users, which are reasonable and customary in accordance with generally accepted practices in the pharmaceutical industry (whether in the form of a credit or free Product), taxes (the legal incidence of which is on the purchaser and is shown separately on a Party's invoices) and transportation, insurance and postage charges (if billed on a Party's invoices as a separate item), and payments and rebates (including Medicaid rebates given pursuant to an agreement with U.S. Department of Health and Human Services and other rebates given pursuant to a government based rebate program, including local and state rebate programs), accrued, paid or deducted pursuant to agreements (including managed care agreements and group purchasing agreements) or Applicable Laws, chargebacks and reporting rebates paid to wholesalers and other distributors. (ii) Excise and value added taxes applicable to sales of the Product which a Party has to pay or absorb on such sales. The Product shall be considered "sold" when billed out or invoiced. No deductions shall be made from Net Sales for items (i) and (ii) above except to the extent of amounts for such items actually granted or paid with respect to the Product; provided that a Party may reconcile such amounts within a given calendar quarter.
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NDA Submission means notification from the FDA indicating acceptance for the filing of the NDA in the United States for the Product for use in the Indication.
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Related to NDA 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 Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • 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.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Licensed Product as a drug in a regulatory jurisdiction.

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • IND means (a) an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, or (b) the equivalent application to the equivalent agency in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

  • Regulatory Materials means materials developed or compiled in preparation for Regulatory Authority meetings, regulatory applications, submissions, dossiers, notifications, registrations, Regulatory Approvals and/or other filings made to or with, or other approvals granted by, a Regulatory Authority that are necessary or reasonably desirable for the Development, manufacture, market, sale, or Commercialization of a Licensed Product in a particular regulatory jurisdiction.

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

  • DMF means any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • JDC has the meaning set forth in Section 3.2.

  • Regulatory Filings means any submission to a Regulatory Authority of any appropriate regulatory application together with any related correspondence and documentation, and will include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

  • Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Regulatory Approval means, with respect to the Licensed Product in any country or jurisdiction, all approvals (including, where required, pricing and reimbursement approvals), registrations, licenses or authorizations from the relevant regulatory authority in a country or jurisdiction that is specific to the Licensed Product and necessary to market and sell such Licensed Product in such country or jurisdiction.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.