Purple Book definition

Purple Book means "Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations", an FDA publication that is commonly referred to as the "Purple Book".
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Purple Book has the meaning set forth in Section 12.8.
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Purple Book means the United States Food and Drug Administration's "Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations" publication and its cumulative supplements, which include lists of licensed biological products with biosimilarity and interchangeability evaluations.
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Examples of Purple Book in a sentence

  • The following paragraphs of the Purple Book and the Manual Handbook remain as part of the new national agreement until superseded by local arrangements following local reviews of grading structure.

  • The following paragraphs of the Purple Book and the Manual Handbook remain as part of the new national agreement until 31 March 1999: Purple Book - Paragraph 38 Manual Handbook - Section 5 Note: A separate document will be produced setting out the details of the provisions remaining in the agreement.


More Definitions of Purple Book

Purple Book means the FDA’s Purple Book Database of FDA-licensed biological products or any replacement thereof established or approved by the FDA.
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Purple Book has the meaning set forth in Section 7.5 (Patent Listing).
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Purple Book means FDA’s List of Licensed Biological Products with Reference Product Exclusivity and
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Purple Book means the United States Food and Drug Administration’s “List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations” publication and its cumulative supplements, which include a list of licensed biological products with biosimilarity and interchangeability evaluations.”
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Purple Book means the electronic or hard copy version of the FDA’s publication, Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, and any successor publication thereto or equivalent publication thereof.
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Related to Purple Book

  • DAILY LOG BOOK means the format as may be certified by the Company's Engineer on a day-to-day basis during the tenure of this Agreement.

  • Master Account Approval List means the list of Attendee reservations and Dates which the Judicial Council has authorized the Contractor to xxxx associated sleeping room charges and tax against the Judicial Council’s Master Account.

  • Open Item List means a list of work activities, Punchlist items, changes or other issues that are not expected by Owner and Contractor to be complete prior to Substantial Completion.

  • City Ledger Report means a list submitted by the Contractor indicating on a daily basis its total number of sleeping room nights rented as well as the total number for sleeping rooms removed from its available inventory or rentals, for purposes of repair.

  • Open Book Data means complete and accurate financial and non-financial information which is sufficient to enable the Customer to verify the Call Off Contract Charges already paid or payable and Call Off Contract Charges forecast to be paid during the remainder of this Call Off Contract, including details and all assumptions relating to: the Supplier’s Costs broken down against each Good and/or Service and/or Deliverable, including actual capital expenditure (including capital replacement costs) and the unit cost and total actual costs of all hardware and software; operating expenditure relating to the provision of the Services including an analysis showing: the unit costs and quantity of goods and any other consumables and bought-in services; manpower resources broken down into the number and grade/role of all Supplier Personnel (free of any contingency) together with a list of agreed rates against each manpower grade; a list of Costs underpinning those rates for each manpower grade, being the agreed rate less the Supplier’s Profit Margin; and Overheads; all interest, expenses and any other third party financing costs incurred in relation to the provision of the Services; the Supplier Profit achieved over the Call Off Contract Period and on an annual basis; confirmation that all methods of Cost apportionment and Overhead allocation are consistent with and not more onerous than such methods applied generally by the Supplier; an explanation of the type and value of risk and contingencies associated with the provision of the Services, including the amount of money attributed to each risk and/or contingency; and the actual Costs profile for each Service Period.

  • Approved List means Securities followed by the Global Fundamental Research Group and tracked on the Approved List. Securities may be added, removed, or undergo periodic ratings changes.

  • Regulatory Flood Protection Elevation means the “Base Flood Elevation” plus the “Freeboard”. In “Special Flood Hazard Areas” where Base Flood Elevations (BFEs) have been determined, this elevation shall be the BFE plus two (2) feet of freeboard. In “Special Flood Hazard Areas” where no BFE has been established, this elevation shall be at least two (2) feet above the highest adjacent grade.

  • Digital book means a work that is generally recognized in the ordinary and usual sense as a book.

  • Orange Book means the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations, as may be amended from time to time.

  • Clinical record means a legible electronic or hard-copy history that documents the criteria established for medical records as set forth in rule 441—79.3(249A). A claim form or billing statement does not constitute a clinical record.

  • Update means a modification to a Component System necessary to maintain the operation of the Component System in compliance with the Documentation in effect as of the Component System’s applicable License Effective Date and includes without limitation modifications correcting any design or operational errors in the Component System and modifications enabling the Component System to be operated in any revised operating environment issued by BNYM and excludes Upgrades.

  • Map means the Flood Hazard Boundary Map (FHBM) or the Flood Insurance Rate Map (FIRM) for a community issued by FEMA.

  • Vital record means that term as defined in section 2805 of the public health code, 1978 PA 368, MCL 333.2805.

  • Request regarding a list of collateral means a record authenticated by a debtor requesting that the recipient approve or correct a list of what the debtor believes to be the collateral securing an obligation and reasonably identifying the transaction or relationship that is the subject of the request.

  • Progress Schedule means a schedule of the Work, in a form satisfactory to Owner, as further set forth in Section 3.02.

  • Coordinated licensure information system means an integrated process for collecting, storing, and sharing information on nurse licensure and enforcement activities related to nurse licensure laws that is administered by a nonprofit organization composed of and controlled by licensing boards.

  • Departmental Schedule , which means the Public Works Department Schedule of Rates in different district of West Bengal for the working area including up-to-date addenda and corrigenda, if any.

  • Switched Access Detail Usage Data means a category 1101xx record as defined in the EMI iconectiv Practice BR 010-200-010.

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

  • Regulatory Floodway means the channel of a river or other watercourse and the adjacent land areas that must be reserved in order to discharge the base flood without cumulatively increasing the water surface elevation more than a designated height.

  • Summary report means the year end report containing the summary of a