Initial Product NDA definition

Initial Product NDA means NDA22529.
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Examples of Initial Product NDA in a sentence

  • Alma MaterLyrics by “Doc” Wilson and Cami Nihipali; Music by “Doc” Wilson Hail Navigators! Oh, we sing to silver, blue, and gold.Na Ho`okele going forth to the future prepared and bold.

  • Upon FDA approval of the Initial Product NDA, Arena shall cause Arena US to transfer the Initial Product NDA to Eisai and to provide to the FDA (with a copy to Eisai) a letter indicating that ownership and a copy of all applicable documents with respect to the Initial Product NDA have been transferred to Eisai pursuant to 21 C.F.R. 314.72.

  • Arena shall thereafter use diligent efforts to provide Eisai a copy of the applicable documents, and Eisai shall use diligent efforts to provide to the FDA commitments to all applicable regulatory requirements relevant to the Initial Product NDA pursuant to the applicable regulations.

  • The Manufacturing Working Group shall work in good faith to use Commercially Reasonable Efforts to maximize the shelf life of all Initial Product delivered to Eisai from the date of FDA approval of the Initial Product NDA to the end of the third month after the First Commercial Sale of the Initial Product in the United States.

  • For clarity, development of the Initial Formulation for Indications other than the Indications that, as of the 2nd Amendment Effective Date, are the subject of the Initial Product NDA shall not be considered Non-Required U.S. Development and shall instead be considered development of an Additional Product under Section 3.3.

  • Right of Way personnel are always in attendance to discuss the acquisition and relocation procedures.

  • The area of the building is expected to be approximately 14,257 square metres.Income support provisionsThe Vendor has agreed to pay a sub trust of the Fund any shortfall in rental income to the extent that in a particular month the Fund receives rental income from premises which are unlet at Completion which is less than if those premises had been let out at the rates set out in the 2006 Jones Lang LaSalle valuation.

  • The Manufacturing Working Group shall work in good faith to use Commercially Reasonable Efforts to maximize the shelf life of all Initial Product delivered to Eisai from the date of FDA approval of the Initial Product NDA to the end of the third month after the First Commercial Sale of the Initial Product.

  • The Government of the Philippines recently requested Bank support to finance the identified interventions in the basin through the proposed Pasig-Marikina River Basin Flood Management Project (PMRBFMP; P171897).

  • Arena US has filed the Initial Product NDA with the FDA, and Arena has conducted (or caused Arena US to conduct), the regulatory activities with respect to the FDA for the Initial Product through achievement of initial Regulatory Approval in the United States for the Initial Product (resulting in the approved Initial Product NDA).

Related to Initial Product NDA

  • Commercial Product means any such product as defined in FAR 2.101.

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

  • Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Additional Products means products, services and applications that are not part of the Services but that may be accessible, via the Admin Console or otherwise, for use with the Services.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • 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.

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation:

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • ANDA means an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • New Products means any product which is not an Enhanced Product or 2 Existing Product but which is substantially similar to an Existing Product with respect to design and function and possesses reasonable performance improvements. If Company desires to purchase an Enhanced or New Product(s) from Supplier, Company shall so notify Supplier and provide Supplier the opportunity to manufacture such Enhanced or New Product(s), subject to the following conditions and procedures.

  • 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.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • 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.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.