Animal Drug Application definition

Animal Drug Application means a New Animal Drug Application and any related supplemental applications and an Abbreviated New Animal Drug Application submitted to the FDA pursuant to 21 U.S.C. 360b (or its successor statutory provision), a Conditional New Animal Drug Application submitted to the FDA pursuant to 21 U.S.C. 360ccc (or its successor statutory provision), a request for an index listing submitted to the FDA pursuant to 21 U.S.C. 360ccc-1 (or its successor statutory provision), a request for authorization for veterinary medical products for use in emergencies submitted to the FDA pursuant to 21 U.S.C. 360bbb-3 (or its successor statutory provision), and a Veterinary Master File, or the equivalent application or filing filed with any equivalent regulatory agency or governmental authority outside the U.S. necessary to sell a Regulated Product in such jurisdiction (including a marketing authorization application or dossier filed with the applicable regulatory agency of a European Union member state or with the European Medicines Agency for a veterinary medicinal product).
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Examples of Animal Drug Application in a sentence

  • Theorphan designation has af forded the firm waivers from Environmental Impact Assessments and application,product and establishment user fees, as well as market exclusivit y.• Developed the strategy and process for all electronic submissions to FDA and EMA .• Lead a team in preparation and submission of the first ever New Animal Drug Application for the DNA construct used to generate the transgenic animals.

  • Within thirty days from the first notification by the FDA of approval of a New Animal Drug Application ("NADA"), the Company will pay the non-refundable sum of $750,000 to Innovet.Any one-off lump sum payments received by the Company as consideration for granting a sub-license to a Commercial Partner with respect to a Licensed Product, shall require the Company to pay to Innovet 14% of the lump sum payment received by the Company.

  • Freedom of Information Summary, Supplemental New Animal Drug Application, NADA 038-233 Ralgro and Ralgro Magnum (Zeranol) 2005 [Accessed: 25 September 2013].

  • FDA is evaluating the GE salmon under its New Animal Drug Application Process (NADA), because the recombinant DNA construct that is intended to change the fish meets the definition of a drug as defined under the Federal Food, Drug, and Cosmetic Act.

  • Drug sponsors must submit a New Animal Drug Application (NADA) along with supporting data, including all adverse effects associated with the drug's use.

  • To determine the regulatory review period for an animal drug where the New Animal Drug Application (NADA) components were submitted to FDA in a phased review, the approval phase, as defined by 35 U.S.C. 156(g)(4)(B)(ii), begins on the date of the submission of the administrative NADA.

  • An approved New Animal Drug Application (NADA) exists for this indication.

  • Formalin (also known by the trade names Formalin-F®, Paracide-F®, PARASITE-S®) is approved through FDA’s New Animal Drug Application (NADA) program for use in controlling external protozoa and monogenetic trematodes on fish, and for controlling fungi of the family Saprolegniacae in food-producing aquatic species.

  • Thus, TIMP-3 may inhibit proteolysis not only by local inhibitory acitivity, but also by preventing MMP-production.

  • No approval has been granted by the FDA for the marketing and sale of ZAN-100.NO APPROVAL HAS BEEN GRANTED BY THE FDA FOR THE MARKETING AND SALE OF ZAN-200A New Animal Drug Application for ZAN-200 has not been submitted to the FDA.

Related to Animal Drug Application

  • New Drug Application means a new drug application in the United States for authorization to market a product, as defined in the applicable laws and regulations and submitted to the FDA.

  • Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • FFDCA means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).

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

  • Drug addiction means a disease characterized by a

  • FD&C Act means the United States Federal Food, Drug and Cosmetic Act, as amended.

  • 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.

  • Prescription drug order means an original or new order from a practitioner for drugs, drug-related devices or treatment for a human or animal, including orders issued through collaborative care agreements. Lawful prescriptions result from a valid practitioner-patient relationship, are intended to address a legitimate medical need, and fall within the prescribing practitioner's scope of professional practice;

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

  • ANDA means Abbreviated New Drug Application.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

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

  • MHLW means the Japanese Ministry of Health, Labour and Welfare, and any successor agency thereto.

  • 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.

  • Drug Master File or “DMF” is described in 21 C.F.R. Part 314.420. A DMF is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

  • 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.

  • New drug means: (i) any drug, except a new animal drug or an animal feed bearing or containing

  • Drug means (i) articles or substances recognized in the official United States Pharmacopoeia

  • Planning Application means the application for [outline/full] planning permission dated [ ] bearing the Council’s reference number [ ];

  • 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.

  • cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epi­ dermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;

  • IND means an investigational new drug application filed with the FDA with respect to a Product, or an equivalent application filed with a Regulatory Authority in a country other than the United States to commence a clinical trial of pharmaceutical product.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.