FDA Application Integrity Policy definition

FDA Application Integrity Policy has the meaning set forth in Section 3.28(d).
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FDA Application Integrity Policy means the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991);
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FDA Application Integrity Policy shall have the meaning ascribed to such term in Section 3.1(u).
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Examples of FDA Application Integrity Policy in a sentence

  • Neither the Company nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy.

  • Neither the Company nor any of its officers, employees, or, to the Company’s knowledge, any of its contractors or agents is the subject of any pending or threatened investigation by FDA pursuant to the FDA Application Integrity Policy and any amendments thereto, or by any other similar governmental entity pursuant to any similar policy.

  • Neither the Company nor any of its officers or employees, or, to the Company’s knowledge, any of the Company’s independent contractors or Agents or any its manufacturing or clinical service providers, has committed any act, made any statement, or failed to make any statement, in each case with respect to the Company, that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy.

  • Neither the Corporation nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy.

  • Neither the CompanyCorporation nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy.

  • Neither Seller nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar Governmental Authority to invoke a similar policy.

  • Neither such Seller, nor, to the Knowledge of Seller, any of its officers, employees, contractors or agents is the subject of any pending or, to the Knowledge of Seller, threatened investigation by the FDA, EMA or any other Regulatory Authority that could reasonably result in the invocation of the FDA Application Integrity Policy or any similar policy by any Regulatory Authority.

  • Neither the Company nor any of its officers or employees, or to the Knowledge of the Company, any of its contractors and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy.

  • The contractor shall not use or store any poisonous or highly inflammable substances on the premises for the rendering of the services or any other purposes without the written consent of the AGSA.

  • Neither Parent nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy.


More Definitions of FDA Application Integrity Policy

FDA Application Integrity Policy is defined in Section 4.1(g)(ii).
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FDA Application Integrity Policy has the meaning set forth in Section 4.12(b) of this Agreement.
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FDA Application Integrity Policy has the meaning set forth in Section 1.1(a).
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FDA Application Integrity Policy is defined in Section ‎‎‎3.15.2.
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FDA Application Integrity Policy is defined in Section 2.5.5.
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FDA Application Integrity Policy has the meaning specified in Section 5.31.
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Related to FDA Application Integrity Policy

  • StarCompliance Code of Ethics application means the web-based application used to electronically pre-clear personal securities transactions and file many of the reports required herein. The application can be accessed via the AB network at: https://alliance-ng.starcompliance.com/.

  • Application Review Start Date means the later date of either the date on which the District issues its written notice that the Applicant has submitted a completed Application or the date on which the Comptroller issues its written notice that the Applicant has submitted a completed Application and as further identified in Section 2.3.A of this Agreement.

  • Insurance Affordability Program means a program that is one of the following:

  • Database application form means the application form required by the Hibiscus Coast Municipality to be filled in by the successful tenderer, following the award of the contract, for inclusion on the HCM database before payment is made.

  • DHHS means the Department of Health and Human Services.

  • Basic Comprehensive User Guide means the Ministry document titled Basic Comprehensive Certificates of Approval (Air) User Guide” dated April 2004 as amended.

  • Quality Assurance Program means the overall quality program and associated activities including the Department’s Quality Assurance, Design-Builder Quality Control, the Contract’s quality requirements for design and construction to assure compliance with Department Specifications and procedures.

  • Medication administration means the direct application of a medication or device by ingestion, inhalation, injection or any other means, whether self-administered by a resident, or administered by a guardian (for a minor), or an authorized health care provider.

  • Data Protection Impact Assessment means an assessment by the Controller of the impact of the envisaged processing on the protection of Personal Data.

  • National Flood Insurance Program means the program created by the U.S. Congress pursuant to the National Flood Insurance Act of 1968 and the Flood Disaster Protection Act of 1973, as revised by the National Flood Insurance Reform Act of 1994, that mandates the purchase of flood insurance to cover real property improvements located in Special Flood Hazard Areas in participating communities and provides protection to property owners through a Federal insurance program.

  • Renewal Application means a document used to collect pertinent data for renewal of permits

  • Mobile Application means a specialized software program downloaded onto a wireless communication device.

  • Client Application means an application developed by Licensee that a) utilizes the Runtime Product, b) is installed fully on an end user’s machine, with all report processing local to that machine, and c) adds significant and primary functionality to the Runtime Product.

  • Cathodic protection tester means a person who can demonstrate an understanding of the principles and measurements of all common types of cathodic protection systems as applied to buried or submerged metal piping and tank systems. At a minimum, such persons must have education and experience in soil resistivity, stray current, structure-to-soil potential, and component electrical isolation measurements of buried metal piping and tank systems.

  • Uniform application means the current version of the national association of insurance commissioners uniform application for resident and nonresident insurance producer licensing.

  • Managed care plan means a health benefit plan that either requires a covered person to use, or

  • CREFC® Significant Insurance Event Template A report substantially in the form of, and containing the information called for in, the downloadable form of the “Interest Significant Insurance Event Template” available as of the Closing Date on the CREFC® Website, or such other form for the presentation of such information and containing such additional information as may from time to time be approved by the CREFC® for commercial mortgage securities transactions generally.

  • Access Application means an application for Access Rights as described in section 3.7;

  • Practical application means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is being utilized and that its benefits are, to the extent permitted by law or government regulations, available to the public on reasonable terms.

  • District and high school graduation report means a report of the number of pupils, excluding adult education participants, in the district for the immediately preceding school year, adjusted for those pupils who have transferred into or out of the district or high school, who leave high school with a diploma or other credential of equal status.

  • Paycheck Protection Program means loan program created by Section 1102 of the CARES Act.

  • Procurement Process means the process commenced by the issuing of this Invitation and concluding upon the award of a contract (or other outcome as determined by Tetra Tech International Development) or upon the earlier termination of the process

  • Customer Application means a software program in Object Code format that Customer has created and which integrates, in whole or in part, Value Added Technology, a Source Code Output File and/or a Binary Output File.

  • Software Application means a digital product or service as defined in Article 2, point 13, of Regulation (EU) …/… [on contestable and fair markets in the digital sector (Digital Markets Act)];

  • Basic health plan model plan means a health plan as required in RCW 70.47.060(2)(e).

  • Commercial applicator means a person who, by contract or for hire, engages in the