Drug Applications definition

Drug Applications means new drug applications, abbreviated new drug applications, biologic license applications or 351(k) biologic license applications (or equivalent non-U.S. applications of any of the foregoing);
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Examples of Drug Applications in a sentence

  • For all items, with FDA required 'New Drug Applications' or 'Abbreviated New Drug Applications', manufacturers shall hold an NDA or ANDA, which shall be in effect at the time of the bid.

  • Guidance: Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs.

  • FDA Guidance for Clinical Investigators, Sponsors, and IRBs Investigational New Drug Applications (INDs)) Determining Whether Human Research Studies Can Be Conducted Without an IND, September 2013: https://www.fda.gov/downloads/drugs/guidances/ucm229175.pdf.

  • The first of these consist of Abbreviated New Drug Applications, or ANDAs. An ANDA allows an independent generic applicant to obtain marketing approval by demonstrating that the proposed product is bioequivalent to an approved pioneer drug, without providing evidence of safety and effectiveness from clinical data or from the scientific literature.

  • Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed, 68 Fed.

  • Patent LitigationWe are engaged in the following patent litigation matters brought pursuant to procedures set out in the Hatch-Waxman Act (the Drug Price Competition and Patent Term Restoration Act of 1984):• Cymbalta: Sixteen generic drug manufacturers have submitted Abbreviated New Drug Applications (ANDAs) seeking permission to market generic versions of Cymbalta prior to the expiration of our relevant U.S. patents (the earliest of which expires in 2013).

  • Manual of Standard Operating Procedures and Policies Investigational New Drug; Issuance of and Response to Clinical Hold Letters for Investigational New Drug Applications, SOPP 8201, Version #3, April 27, 1999, http://www.fda.gov/cber/regsopp/8201.htm.

  • The impact of height on the risk of atrialfibrillation: the Cardiovascular Health Study.

  • We have a broad portfolio of Abbreviated New Drug Applications (“ANDAs”) for our International Generic business filed with the United States Food and Drug Administration (“USFDA”).

  • ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA.

Related to Drug Applications

  • 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.

  • New Drug Application means a New Drug Application filed with the FDA in accordance with Applicable Law.

  • Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

  • 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.

  • 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.

  • FDA means the United States Food and Drug Administration.

  • FD&C Act means the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder.

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

  • 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).

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

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

  • 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.

  • 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 a lawful order of a practitioner for a drug or device for a specific patient that is communicated to a pharmacist.

  • 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.

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

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

  • MHLW means the Ministry of Health, Labour and Welfare of Japan, or the successor thereto.

  • Drug addiction means a disease characterized by a

  • 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.

  • Land use application means an application required by a municipality's land use

  • Patent Cooperation Treaty means the Patent Cooperation Treaty done at Washington on June 19, 1970;

  • 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.

  • IND means (i) an investigational new drug application filed with the FDA for authorization to commence clinical studies and its equivalent in other countries or regulatory jurisdictions and (ii) all supplements and amendments that may be filed with respect to the foregoing.

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.