FDA Documents definition

FDA Documents has the meaning ascribed to such term in Section 4.7.
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FDA Documents is defined in Section 4.32.
Sample 1

Examples of FDA Documents in a sentence

  • INTRODUCTION 1.1 Documents and Data Reviewed 1.1.1 FDA Documents 1.

  • The request was sent to the FDA official involved in formulating the challenged Advisory, Dr. David Acheson, as well as the FDA Documents Management Branch, the FDA Office of the Ombudsman, the Director of the office that disseminated the challenged Advisory, the Center for Food Safety and Applied Nutrition, Dr. Robert E.

  • Freese & Schubert, supra note 136, at 307 (“[T]hese issues were recognized by FDA scientists in the early 1990’s, but their recommendations to require testing for unintended effects were overruled.”); see Key FDA Documents Revealing Hazards of Genetically Engineered Foods—And Flaws with How the Agency Made Its Policy, ALLIANCE FOR BIO-INTEGRITY, http://3dd.816.myftpupload.com/24-fda-documents (last visited Dec.

  • Otherwise it possible to shift the whole database part of the DSS to external hosts.

  • Charles Seife, FDA Documents Reveal Depths of Internal Rancor Over Drug’s Approval Process, UNDARK (Aug.

  • Supplementary FDA Documents Completed site-specific 1572 and 3454 forms in section 5.2 of the SIF.

Related to FDA Documents

  • Contractor Documents means one or more document, agreement or other instrument required by Contractor in connection with the performance of the products and services being purchased by the State, regardless of format, including the license agreement, end user license agreement or similar document, any hyperlinks to documents contained in the Contractor Documents, agreement or other instrument and any other paper or “shrinkwrap,” “clickwrap,” “browsewrap” or other electronic version thereof.

  • Bid Documents means all the documents issued by the Chief Procurement Officer, or referenced by the Chief Procurement Officer as being available on the City's website and incorporated by such reference, in connection with an invitation for bids or proposals. Except for such Bid Documents as are posted on the City's website and incorporated by reference, all Bid Documents must be submitted by a bidder on the Bid Opening Date.

  • Term Documents means the Term Credit Agreement, the Term Guaranties, the Term Collateral Documents, any Term Hedging Agreements between any Term Loan Party and any Term Hedging Affiliate, those other ancillary agreements as to which the Term Agent or any Term Lender is a party or a beneficiary and all other agreements, instruments, documents and certificates, now or hereafter executed by or on behalf of any Term Loan Party or any of its respective Subsidiaries or Affiliates, and delivered to the Term Agent, in connection with any of the foregoing or any Term Credit Agreement, in each case as the same may be amended, supplemented, restated or otherwise modified from time to time.

  • Financing Documents means collectively the documents evidencing Lenders’ commitment to finance the Project.

  • Bidding Documents means the set of Bidding Documents that preceded the placement of the Contract of which these GCC form a part, which were sold or issued by the Purchaser to potential Bidders, and in which the specifications, terms and conditions of the proposed procurement were prescribed.

  • L/C Documents means the Letters of Credit, any draft or other document presented in connection with a drawing thereunder, the Applications and this Agreement.

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

  • Debt Financing Documents means the agreements, documents and certificates contemplated by the Debt Financing.

  • Restructuring Documents means, collectively, the documents and agreements (and the exhibits, schedules, annexes and supplements thereto) necessary to implement, or entered into in connection with, this Plan, including, without limitation, the Plan Supplement, the Exhibits, the Plan Schedules, the Amended/New Organizational Documents, the Exit Facility Loan Documents, and the Plan Securities and Documents.

  • Assigned Documents has the meaning assigned to that term in Section 2.12.

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

  • Senior Documents means, collectively, with respect to any Senior Obligation, any provision pertaining to such Senior Obligation in any Loan Document or any other document, instrument or certificate evidencing or delivered in connection with such Senior Obligation.

  • Project Documents means all documents relating to the Construction Loan, Mortgage Loan and Construction Contract. It shall also include all documents required by any governmental agency having jurisdiction over the Apartment Housing in connection with the development, construction and financing of the Apartment Housing, including but not limited to, the approved Plans and Specifications for the development and construction of the Apartment Housing.

  • Buyer Documents has the meaning set forth in Section 5.2.

  • Subordinated Documents means the Subordinated Note and any and all other documents, agreements, writings or instruments executed in connection therewith or pursuant thereto, in each case, as in effect on the date hereof and as amended, modified, restated or Refinanced in accordance with the terms hereof.

  • Bond Documents means the Bonds, the Indenture, the Loan Agreement, the Remarketing Agreement, the Remarketing Circular, and all amendments and supplements thereto.

  • Procurement Documents means the procurement documents attached hereto as Schedule F (if any);

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

  • Related Documents mean and include without limitation all promissory notes, credit agreements, loan agreements, environmental agreements, guaranties, security agreements, mortgages, deeds of trust, and all other instruments, agreements and documents, whether now or hereafter existing, executed in connection with the Indebtedness.

  • Formation Documents means, collectively, the Issuer LLC Agreement, the Issuer Certificate of Formation and any other document pursuant to which the Issuer is formed or governed, as each may be amended or supplemented from time to time.

  • Equity Documents means collectively the documents evidencing subscription to Equity to the extent of equity component of cost of the Project.

  • Facility Documents means this Agreement, the Notes, the Account Control Agreement, the Collateral Agent Fee Letter, the Custodian Agreement, the Lender Fee Letter, the BNP Fee Letter, the Loan Sale Agreement and any other security agreements and other instruments entered into or delivered by or on behalf of the Borrower pursuant to Section 5.01(c) to create, perfect or otherwise evidence the Collateral Agent’s security interest in the Collateral.

  • Junior Documents means, collectively, with respect to any Junior Obligations, any provision pertaining to such Junior Obligation in any Loan Document or any other document, instrument or certificate evidencing or delivered in connection with such Junior Obligation.

  • Borrower Documents shall have the meaning set forth in Section 6.06.

  • Enclosed Documents [ ] Promissory Note [ ] Primary Insurance Policy [ ] Mortgage or Deed of Trust [ ] Assignment(s) of Mortgage or Deed of Trust [ ] Title Insurance Policy [ ] Other: Name: Title: Date: EXHIBIT G-1 FORM OF TRANSFER AFFIDAVIT AND AGREEMENT STATE OF ) ) ss.: COUNTY OF ) [NAME OF OFFICER], being first duly sworn, deposes and says: