New Drug Approval definition

New Drug Approval means an approval by a Regulatory Authority of a Drug Approval Application.
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.

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.

  • Any new FDA Approved Drug Product or Technology (including but not limited to medications, medical supplies, or devices) available in the marketplace for dispensing by the appropriate source for the product or technology, including but not limited to Pharmacies, for the first six months after the product or technology received FDA New Drug Approval or other applicable FDA approval.

  • Any new FDA Approved Drug Product or Technology ( including but not limited to medications, medical supplies, or devices) available in the marketplace for dispensing by the appropriate source for the product or technology, including but not limited to Pharmacies, for the first six months after the product or technology received FDA New Drug Approval or other applicable FDA approval.

  • Berry and Robert P.Martin, Drugs and the Pharmaceutical Sciences,Vol.185, Informa Health care Publishers.3. New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino, MD,5th edition, Drugs and the Pharmaceutical Sciences,Vol.190.4. Guidebook for drug regulatory submissions / Sandy Weinberg.

  • Informa Health care Publishers.3. New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino, MD, 5th edition, Drugs and the Pharmaceutical Sciences,Vol.190.4. Guidebook for drug regulatory submissions / Sandy Weinberg.

  • Subsequent to this review, the report is forwarded to the MHLW, where the Minister grants the new drug approval.171 At this point, the MHLW prepares a New Drug Approval Information Package (NAIP) based on the review data.

  • The billed charges must not exceed any limitation established by Medicare or state law.Member - A Subscriber or Dependent who has satisfied the eligibility conditions; applied for coverage; been approved by the Plan; and for whom Premium payment has been made.Members are sometimes called ”you” and ”your”.New FDA Approved Drug Product or Technology - The first release of the brand name product or technology upon the initial FDA New Drug Approval.

  • Any New FDA Approved Drug Product or Technology (including but not limited to medications, medical supplies, and/or devices) available in the marketplace for dispensing by the appropriate source for the product or technology, including but not limited to Pharmacies, is excluded from coverage for the first 6 months after the date the product or technology received FDA New Drug Approval or other applicable FDA approval.

  • New FDA Approved Drug Product or Technology - The first release of the brand name product or technology upon the initial FDA New Drug Approval.

  • For pharmaceutical products, milestone payments payable upon first Investigative New Drug Approval, upon positive outcome of Phase II trial in first indication, and upon New Drug Application approval.

Related to New Drug Approval

  • 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 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.

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

  • 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).

  • 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.

  • 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 regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

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

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

  • 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 by the EMEA of a marketing authorization application (“MAA”) filed with the EMEA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.

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