FDA Authorization definition

FDA Authorization the entitlement or right granted by the FDA to distribute and market the Hormone Program.
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FDA Authorization the entitlement or right granted by the FDA to distribute and market the Products, including, for the avoidance of doubt, the new drug application No. 210583 for Anjeso (IV meloxicam) approved by FDA on February 20, 2020.
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Examples of FDA Authorization in a sentence

  • The FDA Authorization of Direct-to-Consumer Genetic Testing for Three BRCA1/2 Mutations: A Twitter Analysis of the Public’s Response.

  • In this light, the FDA eServices Portal System has been developed to provide a streamlined online platform for FDA Authorization applications.

  • The Acquirer consents to the Respondent Pfizer’s withdrawal of the FDA Authorization.

  • Permit the Acquirer to acquire the FDA Authorization from the holder at no cost should the holder withdraw or discontinue the FDA Authorization for any reason.If Respondents have divested any of the Divestiture Assets or granted or assigned rights to the Divestiture Products to the Acquirer who is named in this Order prior to the Order Date, and if, at the time the Commission determines to make this Order final, the Commission notifies Respondents that:1.

  • The reason for this is that the horizontal turn is providing all of the separation.

  • For a period of 7 years after the term of Paragraph XI.A ends, Prasco or any other Acquirer shall not sell or license, through subsidiaries or otherwise, without the prior approval of the Commission, any FDA Authorizations that were divested pursuant to Section II, to any Person who owns, directly or indirectly, an FDA Authorization, or is seeking approval from the FDA for an FDA Authorization, to manufacture and sell a Therapeutic Equivalent of a Divestiture Product.

  • Pfizer/BioNTech received full FDA Authorization for ages 16 and up on August 23rd, 2021.

  • AB Science Receives U.S. Food and Drug Administration (FDA) Authorization to Resume Patient Enrollment in the Phase 3 Study of Masitinib in Amyotrophic Lateral Sclerosis (ALS).

  • Denied FDA Authorization, Vaping Companies Start to Explore Loopholes.

  • Drew Armstrong, House-Passed FDA Authorization Heads for Contentious Conference, 2007 CQ WEEKLY 2117.

Related to FDA Authorization

  • Product Authorizations means any and all approvals, including applicable supplements, amendments, pre- and post-approvals, clearances, licenses, notifications, registrations, certifications or authorizations of any Governmental Authority, any Standard Body necessary for the manufacture, development, distribution, use storage, import, export, transport, promotion, marketing, sale or other commercialization of a Product in any country or jurisdiction.

  • Sell Authorization means that Distributor needs to meet specific training and qualification requirements for each product included in an “On Premise” Product Family that Distributor wants to resell as set out in detail in the Distributor Program Guide and the applicable RSPI.

  • Prior authorization means that we must approve the Services in advance in order for the Services to be covered.

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • Service Authorization means that Open Ecosystem Partner needs to meet specific qualification requirements for the products included in a “Service” Product Family that Open Ecosystem Partner wants to promote and offer Services for as set out in detail in the Open Ecosystem Program Guide.

  • Work Authorization or "WA" means Buyer’s authorization in either electronic or tangible form for Supplier to conduct transactions under this Agreement in accordance with the applicable SOW (i.e., a purchase order, xxxx of lading, or other Buyer designated document). A SOW is a WA only if designated as such in writing by Buyer.

  • Regulatory Authorizations means all approvals, clearances, notifications, authorizations, orders, exemptions, registrations, certifications, licenses and permits granted by, submitted to or filed with any Regulatory Agencies, including all Product Authorizations.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • ACH Authorization means the ACH Debit Authorization Agreement in substantially the form of Exhibit H.

  • Government Authorizations means all such approvals, consents, authorizations, acknowledgements, licenses or permits required to be issued by any Government Authority to the Company for the establishment of the Company or to the Company or the Contractors for the construction, financing, ownership, operation, and maintenance of the Facility by the Company or the Contractors, including, without limitation, those Government Authorizations listed in Schedule 1;

  • Necessary Authorizations means all approvals and licenses from, and all filings and registrations with, any governmental or other regulatory authority, including, without limiting the foregoing, the Licenses and all approvals, licenses, filings and registrations under the Communications Act, necessary in order to enable the Borrower and its Subsidiaries to own, construct, maintain, and operate communications tower facilities and to invest in other Persons who own, construct, maintain, manage and operate communications tower facilities.

  • Federal work authorization program means any of the electronic verification of work authorization programs operated by the United States Department of Homeland Security or any equivalent federal work authorization program operated by the United States Department of Homeland Security to verify information of newly hired employees, pursuant to the Immigration Reform and Control Act of 1986 (IRCA), D.L. 99-603.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Product Approval(s) means any approvals, registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, sale, storage or transport of a Product within the United States of America, and includes, without limitation, all approvals, registrations, licenses or authorizations granted in connection with any Application related to that Product.

  • Governmental Authorization means any authorization, approval, consent, franchise, license, covenant, order, ruling, permit, certification, exemption, notice, declaration or similar right, undertaking or other action of, to or by, or any filing, qualification or registration with, any Governmental Authority.

  • Environmental Authorization Any license, permit, order, approval, consent, notice, registration, filing or other form of permission or authorization required under any Environmental Law.

  • Private Authorizations means all franchises, permits, licenses, approvals, consents and other authorizations of all Persons (other than Governmental Authorities).

  • Environmental Authorizations means all licenses, permits, orders, approvals, notices, registrations or other legal prerequisites for conducting the business of the Borrower or any Subsidiary required by any Environmental Requirement.

  • Governmental Authorizations means, with respect to any Person, all licenses, permits, certificates, waivers, consents, franchises (including similar authorizations or permits), exemptions, variances, expirations and terminations of any waiting period requirements and other authorizations and approvals issued to such Person by or obtained by such Person from any Governmental Authority, or of which such Person has the benefit under any Applicable Law.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • Service Authorization Request means a Provider’s or Enrollee’s request to the Contractor for the provision of a service.

  • UCC Filing Authorization Letter means a letter duly executed by each Loan Party authorizing the Collateral Agent to file appropriate financing statements on Form UCC-1 without the signature of such Loan Party in such office or offices as may be necessary or, in the opinion of the Collateral Agent, desirable to perfect the security interests purported to be created by each Security Agreement and each Mortgage.

  • 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.

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