New Drug Approval definition

New Drug Approval means an approval by a Regulatory Authority of a Drug Approval Application.
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New Drug Approval means the approval issued to Licensee or any Affiliate or sublicensee of Licensee by the competent Regulatory Authority in the Territory approving the manufacture and commercial sale of a Licensed Product(s) by Licensee or any Affiliate or sublicensee of Licensee within the Territory.
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New Drug Approval means an approval by a Governmental Authority of a Drug Approval Application.
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Examples of New Drug Approval in a sentence

  • New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino, MD,5th edition, Drugs and the Pharmaceutical Sciences,Vol.190.

  • AZEDRA® was approved by the FDA on July 30, 2018 for the treatment of adult and pediatric patients 12 years and older diagnosed with iobenguane scan positive, unresectable, locally advance or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy through a New Drug Approval (NDA) filed under Section 505(b)(1) of the Federal Food, Drug and Cosmetic Act and 21 CFR 314.50.

  • Table 1.1 NDA Goals and Review Times for FY94-96118 115United States Food and Drug Administration, New Drug Approval Time: The Facts, February 22, 2002, available at http://www.fda.gov/oc/pdufa/thefacts/questions.html#question3.116Although the term new drug application is used, the numbers discussed in the text and used in the tables reflect FDA performance on NDAs, PLAs, and ELAs combined.117FDA Third Annual Performance Report: Prescription Drug User Fee Act at 2 (1995).

  • Available at: http://www.fda.gov/cder/rdmt/ accappr.htm; FDA New Drug Approval Report “NDA Supplements Approved Under Subpart H”, updated Mar.

  • INTRACEL shall pay to TJU license fee payments of one hundred thousand dollars ($100,000) per year, upon receiving from the Food and Drug Administration ("FDA") a New Drug Approval ("NDA") to market a Product, and at the beginning of each Agreement Year following such NDA, which shall be creditable in full against running royalties payable pursuant to paragraph 3.01 for the respective Agreement Year.

  • Guarino ed., New Drug Approval Process 5 (Marcel Dekker 1993).31Id.32Id. pharmacology studies and toxicity studies.

  • Charges incurred at Non-Network Pharmacies will be reimbursed based on the amount typically paid to Network Pharmacies for the same drug, minus your Copay.9. New FDA-Approved Drug Product or Technology — The first release of the Brand Name product or technology upon the initial FDA New Drug Approval.

  • New Drug Approval Process: Accelerating Global Registrations By Richard AGuarino, MD,5th edition, Drugs and the Pharmaceutical Sciences,Vol.190.

  • The term of this Agreement shall commence as of the date hereof and continue until the date seven (7) years after the FDA grants a New Drug Approval for 15-AU to be used in the Target Therapy hereunder ("Initial Term"), unless sooner terminated as set forth herein.

  • The molecule has been submitted for New Drug Approval in the US and Europe.

Related to New Drug Approval

  • New Drug Application or “NDA” means a New Drug Application filed with the FDA as described in 21 C.F.R. § 314, a Biological License Application (BLA) pursuant to 21 C.F.R. § 601.2, or any equivalent or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the United States.

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

  • 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 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.

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

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

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

  • Regulatory Approval means any and all approvals, licenses, registrations or authorizations of any Regulatory Authority that are necessary for the marketing and sale of a product in a country or group of countries.

  • 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.

  • 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.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • NDA means a New Drug Application, as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding foreign application, registration or certification.

  • 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.

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

  • ANDA means Abbreviated New Drug Application.

  • FDA Approval means with respect to the Product, a Regulatory Approval by the FDA for the commercial use of the Product in the United States.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the applicable country or jurisdiction, but excluding any Pricing and Reimbursement Approval.

  • 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).

  • Drug addiction means a disease characterized by a

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

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

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

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

  • 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.

  • 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.