FDA Registrations definition

FDA Registrations means authorizations, approvals, licenses, permits, certificates, or exemptions issued by the FDA (including, without limitation, pre-market approval applications, pre-market notifications, investigational new drug applications, new drug applications, biologic license applications, manufacturing approvals and authorizations, pricing and reimbursement approvals, labeling approvals or their foreign equivalent) held by the Company that are required for, among other things, the research, development, manufacture, processing, labeling, distribution, marketing, storage, transportation, use, sale and provision of the products and services of the Company.
Sample 1Sample 2Sample 3
FDA Registrations means all establishment registrations, annual drug or device listings, as defined in 21 C.F.R. §§ 207, 807, and all supplements or amendments thereto.
Sample 1Sample 2
FDA Registrations means all establishment registrations, annual drug or device listings, as defined in 21 C.F.R.§§ 207, 807, and all supplements or amendments thereto.
Sample 1

Examples of FDA Registrations in a sentence

  • Require Food Facilities to Renew Their FDA Registrations Every Two Years, and Allow FDA to Modify the Registration CategoriesFDA requests statutory changes that would require facilities to register every two years and authorize the FDA to establish food categories within the registration system.

  • The primary licenses held in this regard are FDA Registrations of Drug Establishment and Drug Enforcement Administration ("DEA"), Controlled Substance Registration in respect of our Gainesville facility.

  • Both the fiancé and fiancée must be unmarried, widowed or divorced (with Decree Nisi Absolute/ Interim Judgment Final granted) at the time of application.


More Definitions of FDA Registrations

FDA Registrations means authorizations, approvals, licenses, permits, certificates, or exemptions issued by the FDA (including, without limitation, pre-market approval applications, pre-market notifications, investigational new drug
Sample 1

Related to FDA Registrations

  • Company IP Registrations means all Company Intellectual Property that is subject to any issuance registration, application or other filing by, to or with any Governmental Authority or authorized private registrar in any jurisdiction, including registered trademarks, domain names and copyrights, issued and reissued patents and pending applications for any of the foregoing.

  • Business registration means a business registration certificate issued by the Department of the Treasury or such other form or verification that a contractor or subcontractor is registered with the Department of Treasury;

  • Product Registrations shall have the meaning set forth in Section 5.10 hereof.

  • Registration Books means the records maintained by the Trustee pursuant to Section 2.08 for the registration and transfer of ownership of the Bonds.

  • international registration means the registration of a mark effected under the Agreement or the Protocol or both, as the case may be;

  • Provisional registration means a building official, plan reviewer, or inspector who is registered subject to his or her completion of the amount of training, education, and experience required by the commission and the appropriate advisory board and described in section 1007(2).

  • Withdrawn Registration means a forfeited demand registration under Section 2.1 in accordance with the terms and conditions of Section 2.4.

  • Incidental Registration has the meaning set forth in Section 4(a) of this Agreement.

  • Exchange Registration shall have the meaning assigned thereto in Section 3(c) hereof.

  • Registration Data means certain personal and financial information that you are required to provide in order to complete the Account Opening Application Form and become our Client, such information can include without limitation a copy of your passport, driving license and/or Photo identity card.

  • registration refer to a registration effected by preparing and filing a registration statement in compliance with the Securities Act, and the declaration or ordering of the effectiveness of such registration statement.

  • Special Registration means the registration of (A) equity securities and/or options or other rights in respect thereof solely registered on Form S-4 or Form S-8 (or successor form) or (B) shares of equity securities and/or options or other rights in respect thereof to be offered to directors, members of management, employees, consultants, customers, lenders or vendors of the Company or Company Subsidiaries or in connection with dividend reinvestment plans.

  • Original Registration Statement. As used in this Agreement, the terms “amendment” or “supplement” when applied to the Registration Statement or the Prospectus shall be deemed to include the filing by the Company with the Commission of any document under the Exchange Act after the date hereof that is or is deemed to be incorporated therein by reference. All references in this Agreement to financial statements and schedules and other information which is “contained,” “included” or “stated” in the Registration Statement or the Prospectus (and all other references of like import) shall be deemed to mean and include all such financial statements and schedules and other information which is or is deemed to be incorporated by reference in or otherwise deemed under the Securities Act to be a part of or included in the Registration Statement or the Prospectus, as the case may be, as of any specified date; and all references in this Agreement to amendments or supplements to the Registration Statement or the Prospectus shall be deemed to mean and include, without limitation, the filing of any document under the Exchange Act which is or is deemed to be incorporated by reference in or otherwise deemed under the Securities Act to be a part of or included in the Registration Statement or the Prospectus, as the case may be, as of any specified date. At the time the Registration Statement was or will be originally declared effective and at the time the Company’s most recent annual report on Form 10-K was filed with the Commission, if later, the Company met the then-applicable requirements for use of Form S-3 under the Securities Act. During the Agency Period, each time the Company files an annual report on Form 10-K the Company will meet the then-applicable requirements for use of Form S-3 under the Securities Act.

  • International registration plan means a reciprocal agreement of member jurisdictions that is endorsed by the American association of motor vehicle administrators, and that promotes and encourages the fullest possible use of the highway system by authorizing apportioned registration of fleets of vehicles and recognizing registration of vehicles apportioned in member jurisdictions.

  • Registration Filing Date means the date that is 60 days after date of the final closing of the PPO.

  • Form S-4 Registration Statement means the registration statement on Form S-4 to be filed with the SEC by Parent in connection with issuance of Parent Common Stock in the Merger, as said registration statement may be amended prior to the time it is declared effective by the SEC.

  • Registration Application means an application for registration of this Agreement as a planning agreement on the title of the Land pursuant to Section 7.6 of the Act in a form approved by the Registrar General;

  • S-3 Registration has the meaning set forth in Section 5(a) of this Agreement.

  • Registration decal means an adhesive sticker produced by the department and issued by the

  • Rule 462(b) Registration Statement means any registration statement prepared by the Company registering additional Securities, which was filed with the Commission on or prior to the date hereof and became automatically effective pursuant to Rule 462(b) promulgated by the Commission pursuant to the Securities Act.

  • Additional Registration Statement means a registration statement or registration statements of the Company filed under the 1933 Act covering any Additional Registrable Securities.

  • New Registration Statement has the meaning set forth in Section 2(a).

  • Short-Form Registrations has the meaning set forth in Section 2(a).

  • Demand Registrations has the meaning set forth in Section 2(a).

  • Additional Registrable Securities means, (i) any Cutback Shares not previously included on a Registration Statement and (ii) any capital stock of the Company issued or issuable with respect to the Notes, the Conversion Shares, the Warrants, the Warrant Shares, or the Cutback Shares, as applicable, as a result of any stock split, stock dividend, recapitalization, exchange or similar event or otherwise, without regard to any limitations on conversion, amortization and/or redemption of the Notes or exercise of the Warrants.

  • Registration Agency on labour standards shall mean the Industrial Training Branch, Ministry of Labour. "Registration Agency" for the apprentice as a student, covering related instruction.