Relevant NDA definition

Relevant NDA means a New Drug Application in the U.S. in relation to a Licensed Product submitted to the FDA by the Licensee under section 505(b)(2) of the U.S Food, Drugs and Cosmetics Act during the NCE Exclusivity Period which is a First U.S. Application for that Licensed Product.

Examples of Relevant NDA in a sentence

  • Discuss risks to schedule and cost.(5 pages, not including Gantt Chart) Qualifications and Experience = 20 points a.

  • Relevant INDs: IND 72,593 (intravenous BAL8557), IND 119,307 (BAL 8557 capsule) Relevant NDA: NDA 207501 (intravenous BAL8557) Relevant DMF: None 2.3.1 Drug Formulation Isavuconazonium sulfate hard capsules are hard capsules containing 186.3 mg isavuconazonium sulfate corresponding to 100 mg isavuconazole (active moiety BAL4815).

  • The share of natural gas power plants in installed capacity was about 31.56% in 2007.

  • Boston, October 2015.• North Carolina Institute of Medicine (NCIOM) August 2015.• State Offices of Rural Health (SORH), July 2015.Appendix H: NC-STeP Scientific Posters1.

Related to Relevant NDA

  • Relevant Number means the number specified as such in the applicable Final Terms (or, if no such number is specified, five);

  • Relevant Ship means the Ships and any other vessel from time to time (whether before or after the date of this Agreement) owned, managed or crewed by, or chartered to, any Relevant Party;

  • Relevant Authorities means any governmental or statutory authority with the

  • Safety Authorisation and “deemed Safety Authorisation” have the meanings given to “safety authorisation” and “deemed safety authorisation” by the Railways and Other Guided Transport Systems (Safety) Regulations 2006;

  • relevant Minister means the Secretary of State or the Minister for the Cabinet Office;

  • relevant week means the reduction week or part-week in which the capital in question of which the applicant has deprived himself within the meaning of paragraph 67(1)—

  • Marketing Authorisation means any approval (including all applicable pricing and governmental reimbursement approvals) required from the FDA or relevant Competent Authority to market and sell a Product in a particular country.

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

  • Relevant Tax Authority means HMRC, or, if applicable, the tax authority in the jurisdiction in which the Supplier is established;

  • relevant system means a relevant system for the holding and transfer of shares in uncertificated form;

  • Relevant UK Resolution Authority means any authority with the ability to exercise a UK Bail-in Power.

  • relevant scheme means a scheme of financial assistance provided under—

  • relevant authority means the authority of which M is a member;

  • Foreign-going vessel means any vessel other than coastal vessel.

  • PMDA means Japan’s Pharmaceuticals and Medical Devices Agency or any successor entity thereto.

  • Relevant Tax means any present or future taxes, duties, assessments or governmental charges of whatever nature, imposed or levied by or on behalf of any Relevant Jurisdiction or any authority therein or thereof having the power to tax.

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

  • Relevant Governmental Body means the Board of Governors of the Federal Reserve System or the Federal Reserve Bank of New York, or a committee officially endorsed or convened by the Board of Governors of the Federal Reserve System or the Federal Reserve Bank of New York, or any successor thereto.

  • Aboriginal as defined in the constitution of Canada, "includes the Indian, Inuit and Métis peoples of Canada".

  • Relevant Agreement means an agreement benefiting persons who receive educational instruction at the School.

  • Relevant Institution means a person that has permission under Part 4A of the Financial Services and Markets Act 2000 (permission to carry on regulated activity).

  • EU GDPR means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC.

  • Relevant Declaration means the declaration relevant to the Shareholder as set out in Schedule 2B of the Taxes Act.

  • Major European Country means any of France, Germany, Italy, Spain or the United Kingdom.

  • Authorisations means any consent, registration, filing, notarisation, licence, approval, permit, authority or exemption from, by or with any Governmental Authority and all corporate, creditors’, shareholders’ and third-party approvals or consents;

  • MFDA means the Mutual Fund Dealers Association of Canada;