Antiviral Products definition

Antiviral Products means Products subject to the [**] Application(s).

Examples of Antiviral Products in a sentence

  • This application is under review in the Division of Antiviral Products (DAVP).

  • DMEPA and the Division of Antiviral Products (DAVP) concurred with the findings of OPDP’s assessment of the proposed name.

  • In response to the OSE, August 10, 2017 e-mail, the Division of Antiviral Products (DAVP) did not forward any comments or concerns relating to the proposed proprietary names at the initial phase of the review.

  • Division of Antiviral Products SUBJECT: Deputy Director Memorandum for NDA 211284Temyxis, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 300mg/300mg APPLICANT: Celltrion Inc.

  • DMEPA and the Division of Antiviral Products (DAVP) concurred with the findings of OPDP’s promotional assessment of the proposed name.

  • DMEPA and the Division of Antiviral Products (DAVP) concurred with the findings of OPDP’s assessment of the proposed names.

  • The Division of Medication Error Prevention and Analysis (DMEPA) and the Division of Antiviral Products (DAVP) concurred with the findings of OPDP’s assessment of the proposed name.

  • All ≥ Grade 2 infusion reactions that occur during the study will be evaluated as to whether or not the event is a DLT, and reviewed with the Division of Antiviral Products (DAVP) of the Food and Drug Administration (FDA).

  • The design of such studies should be discussed with the Division of Antiviral Products (DAVP).

  • To the knowledge of Seller, all reports, documents, forms, claims, applications, records submissions, supplements, amendments, and notices required to be filed with, maintained for or furnished to the FDA or any other Governmental Entity with respect to the Seller Antiviral Products by Seller, have been so filed, maintained or furnished by Seller.

Related to Antiviral Products

  • Marijuana products means concentrated marijuana products and marijuana products that are comprised of marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, ointments, and tinctures.

  • 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.

  • Cannabis products means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Hemp products means all products made from industrial hemp,

  • Marijuana-infused products means products that contain marijuana or marijuana extracts and are intended for human use. The term "marijuana-infused products" does not include useable marijuana.

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • 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.”

  • 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;

  • Mineral Products means the commercial end products derived from operating the Property as a mine:

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Products means information resources technologies that are, or are related to, EIR.

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • 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.

  • Steel Products means products rolled, formed, shaped, drawn, extruded, forged, cast, fabricated or otherwise similarly processed, or processed by a combination of two or more or such operations, from steel made by the open heath, basic oxygen, electric furnace, Bessemer or other steel making process.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

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

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Covered Products means Your Applications, Libraries, Passes, Safari Extensions, Safari Push Notifications, and/or FPS implementations developed under this Agreement.

  • Tobacco products means cigars, cigarettes, cheroots, stogies, periques, granulated, plug cut, crimp cut, ready rubbed, and other smoking tobacco, snuff, snuff flour, moist snuff, cavendish, ping and twist tobacco, fine-cut and other chewing tobaccos, shorts, refuse scraps, clippings, cuttings and sweepings of tobacco, and other kinds and forms of tobacco, prepared in such manner as to be suitable for chewing or smoking in a pipe or otherwise, or both for chewing and smoking.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).