Antiviral Products definition

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

Examples of Antiviral Products in a sentence

  • All of the municipalities within the Oneida Lake watershed have enacted varying levels of land use controls.

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

  • Should circumstances change such that field trials become feasible (e.g., after accidental exposure to or intentional release of variola virus occurs), the sponsor should discuss its development plans with CDER’s Division of Antiviral Products.

  • This guidance has been prepared by the Division of Antiviral Products in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration.

  • Submit data in the HBV Resistance Format provided by the Division of Antiviral Products.

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

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

  • Division of Antiviral Products (DAVP), US Food and Drug Administration.

  • In the case of next-generation sequence analysis, sponsors should refer to the guidance for industry and technical specification document Submitting Next Generation Sequencing Data to the Division of Antiviral Products (July 2019), which describes the 12 Submission of an investigational device exemption to the Center for Devices and Radiological Health may be warranted if an investigational assay is used in a clinical trial.

  • DATE: August 12, 2014 TO: Debra Birnkrant, MD DirectorDivision of Antiviral Products Office of New Drugs FROM: Gajendiran Mahadevan, Ph.D. GLP BranchDivision of Bioequivalence and GLP Compliance Office of Scientific Investigations THROUGH: Charles Bonapace, Pharm.D. Chief, GLP BranchDivision of Bioequivalence and GLP Compliance Office of Scientific Investigations and William H.

Related to Antiviral Products

  • 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.

  • Hemp products means all products made from industrial hemp,

  • 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.

  • 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, 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 the fully assembled and shrink-wrapped Licensed Products, each including a Game Cartridge, Game Cartridge label and Printed Materials.

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

  • 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 Existing Product but which is substantially similar to an of this Agreement, "New Product" or "New Products" shall mean 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. The Purchasing Division Director may, in writing, authorize the use of foreign steel products if:

  • 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).

  • 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 any EZH2 Compound(s) that is: