FDA Guidance Documents definition

FDA Guidance Documents means all applicable guidance documents issued by the FDA (and any foreign equivalent), including policies related to Emergency Use Authorizations, laboratory-developed tests, medical device cybersecurity, mobile medical devices, medical device data systems, medical device storage devices, and medical image communications devices.
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FDA Guidance Documents means all applicable guidance documents issued by the FDA.
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Examples of FDA Guidance Documents in a sentence

  • Keep all Inventory which constitutes Product in good and marketable condition, free from material defects and otherwise keep all Inventory which constitutes Product in material compliance with all applicable FDA Laws, FDA Good Manufacturing Practices, FDA Good Clinical Practice, FDA Good Laboratory Practices and FDA Guidance Documents, as applicable.

  • Sponsor shall (a) track and collect financial disclosure information from all “clinical investigators” involved in each Study and (b) prepare and submit the certification and/or disclosure of the same in accordance with all Applicable Law, including, but not limited to, Part 54 of Title 21 of the United States Code of Federal Regulations (Financial Disclosure by Clinical Investigators) and related FDA Guidance Documents.

  • Company shall (a) track and collect financial disclosure information from all “clinical investigators” involved in the Study and (b) prepare and submit the certification and/or disclosure of the same in accordance with all Applicable Law, including, but not limited to, Part 54 of Title 21 of the United States Code of Federal Regulations (Financial Disclosure by Clinical Investigators) and related FDA Guidance Documents.

  • Subject to the limitations of Section 8.4 (Benefit of Agreement), each Lender may transfer and carry its Loans at, to or for the account of any branch office, Subsidiary or Affiliate of such Lender.

  • Adaptimmune shall (a) track and collect financial disclosure information from all “clinical investigators” involved in the Study and (b) prepare and submit the certification and/or disclosure of the same in accordance with all Applicable Law, including, but not limited to, Part 54 of Title 21 of the United States Code of Federal Regulations (Financial Disclosure by Clinical Investigators) and related FDA Guidance Documents.

  • The Party conducting a Clinical Study under a Right of Reference shall (a) track and collect financial disclosure information from all “clinical investigators” involved in such Clinical Study for such Program and (b) prepare and submit the certification or disclosure of the same in accordance with all applicable Law, including Part 54 of Title 21 of the United States Code of Federal Regulations (Financial Disclosure by Clinical Investigators) and related FDA Guidance Documents.

  • Antigen Express shall (a) track and collect financial disclosure information from all “clinical investigators” involved in the Study and (b) prepare and submit the certification and/or disclosure of the same in accordance with all Applicable Law, including, but not limited to, Part 54 of Title 21 of the United States Code of Federal Regulations (Financial Disclosure by Clinical Investigators) and related FDA Guidance Documents.

  • Confidential Portions are marked: [***] This submission is being submitted in accordance with the current FDA Guidance Documents for the electronic common technical document.

  • Rexahn shall (a) track and collect financial disclosure information from all “clinical investigators” involved in the Study and (b) prepare for submission (and submit as applicable) the certification and/or disclosure of the same in accordance with all Applicable Law, including, but not limited to, Part 54 of Title 21 of the United States Code of Federal Regulations (Financial Disclosure by Clinical Investigators) and related FDA Guidance Documents.

  • Confidential Portions are marked: [***] All future correspondence and regulatory communications concerning NDA 08-975 for Corticotrophin, should be directed to the XXXX: Name Address Telephone Fax DUNS number: E-mail This submission is being submitted in accordance with the current FDA Guidance Documents for the electronic common technical document.

Related to FDA Guidance Documents

  • Reference Documents means the documents provided with and so designated in the RFP. The Reference Documents, including Plans contained therein and/or so designated, are not Contract Documents and were provided to the Design-Builder for informational purposes only and are relied upon at the Design-Builder’s own risk.

  • Finance Documents means these Terms and Conditions, the Agency Agreement and any other document designated by the Issuer and the Agent as a Finance Document.

  • Service Document means a claim form, application notice, order, judgment or other document relating to any Proceedings;

  • Finance Document means this Agreement, any Fee Letter, any Accession Letter, any Resignation Letter and any other document designated as such by the Agent and the Company.

  • Senior Finance Documents means the Senior Facilities Agreement and such other documents identified as “Senior Finance Documents” pursuant to the Senior Facilities Agreement.

  • Scope Document means the document (if any) that is provided with and becomes part of the Order Form and which defines sometimes in conjunction with a Service Description (as applicable) the Services to be provided.

  • Service documentation means all records and information on one or more documents, including documents that may be created or maintained in electronic software programs, created and maintained contemporaneously with the delivery of services, and kept in a manner as to fully disclose the nature and extent of services delivered that shall include the items delineated in paragraph (E) of this rule to validate payment for medicaid services.

  • Principal Finance Documents means the Credit Agreement, the Senior Secured Note Indenture, the Intercreditor Arrangements and any Additional Agreement.

  • Covered contract means a DoD prime contract for an amount exceeding the simplified acquisition threshold, except for a fixed-price contract without cost incentives. The term also includes a subcontract for an amount exceeding the simplified acquisition threshold, except for a fixed-price subcontract without cost incentives under such a prime contract.

  • Programme Document means the formal document (in standard format) attached to this Agreement, which is concluded by the Parties and reflects expected results, detailed activities, timeframes and budget, and defines what is to be accomplished. The Programme Document is the basis for requisitioning, committing and disbursing funds to carry out planned activities and for their monitoring and reporting.

  • Conveyance Documents has the meaning set forth in Section 11.2(a).

  • T E Document means Tender Enquiry Document

  • Application Documents means collectively: (i) the grant application submitted by Grantee, including all exhibits, schedules, appendices and attachments thereto; (ii) all documents, correspondence and other written materials submitted in respect of such grant application; and (iii) all amendments, modifications or supplements to any of the foregoing approved in writing by City.

  • Required Loan Documents means, for each Loan:

  • New Corporate Governance Documents means such certificates or articles of incorporation, bylaws, or such other applicable formation documents of some or all of the Reorganized Debtors, which form shall be consistent with the terms of the Plan and shall be included in the Plan Supplement.

  • DIP Documents means the DIP ABL Documents and the DIP Term Loan Documents.

  • RFP Documents means the following documents to be entered into by the parties to the respective agreements in connection with the supply of power:

  • ABL Loan Documents means the “Loan Documents” as defined in the ABL Credit Agreement.

  • Scheme Document means this document including its Annexures, any addenda or corrigendum to this Scheme Document and/ or any other document issued pursuant hereto.

  • Public Documents As defined in Section 4.02(a) of this Agreement.

  • Offering Document means the prospectus or other document (issued by the Management Company with written consent of the Trustee and approved by the Commission) which contains the investments and distribution policy, unit structure(s) and all other information in respect of the Unit Trust, as required by the Rules and Regulations and is circulated to invite offers by the public to invest in the Scheme.

  • Financing Document means any credit agreement, guarantee, financing or security agreement or other agreements or instruments governing indebtedness of the Company or any of the Company Subsidiaries.

  • Second Lien Loan Documents means the “Loan Documents” as defined in the Second Lien Credit Agreement.

  • Second Lien Credit Agreement means the Second Lien Credit Agreement, dated as of the Closing Dates thereof among the Borrower, the other Credit Parties from time to time party thereto, the Second Lien Lenders and the Second Lien Administrative Agent, as the same may be amended, restated and/or modified from time to time subject to the terms thereof.

  • Underlying Documents means, together, the Contracts, the Refund Guarantees, the Supervision Agreements and the Management Agreements and “Underlying Document” means any of them.

  • Scheme Documents means (a) any Scheme Press Release, (b) the Scheme Circular (if any) and (c) any other document designated in writing as such by Borrower and Administrative Agent.