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The following paragraphs of the Purple Book and the Manual Handbook remain as part of the new national agreement until superseded by local arrangements following local reviews of grading structure.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 31.3.99: 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.

  • Toxic effects, from toxic materials or toxic combustion products.In the next three paragraphs, the chosen damage criteria are given and explained as per the Guidelines for QRA – Phast (Micro) Software (DNV) & Purple Book for QRA released by Centre for Chemical Process Safety (CCPS).

  • Guidance for Controlling ACM in Buildings (Purple Book) EPA 560/5-85- 024 C.

  • The following paragraphs of the Purple Book and the Manual Handbook remain as part of the new national agreement until 31.3.99 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.

  • A licensed biosimilar product determined by the FDA to be therapeutically equivalent to the reference biological product and published in the Purple Book.

  • General and specific considerations concerning labeling requirements are provided in Hazard communication: Labelling (Chapter 1.4) of the UN Purple Book.

  • This SDS is prepared by Product Regulatory Services and Hazard Communications Groups from information supplied by internal references within our company.Classification was done in accordance with UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Purple Book and complies with the Regulations for Hazardous Chemical Agents, 2021.

  • A biological product highly similar to a specific reference biological product that is licensed by the FDA pursuant to 42 U.S.C. Section 262(k) and published in the Purple Book.

  • Ability to bring information such as classes taught and student evaluation scores into Digital Measures for Purple Book and other documentation.


More Definitions of Purple Book

Purple Book means FDA’s List of Licensed Biological Products with Reference Product Exclusivity and
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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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Purple Book has the meaning set forth in Section 6.5 (Patent Listing).
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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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Related to Purple Book

  • Donor profile record means all records about donors or potential donors to a public institution of higher education except the names and reported addresses of the actual donors and the date, amount, and conditions of the actual donation.

  • 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); operating expenditure relating to the provision of the Goods and/or 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 Goods and/or Services, including the amount of money attributed to each risk and/or contingency; and the actual Costs profile for each Service Period.

  • Template Order Form means the template form in Annex 1 to Framework Schedule 4 (Template Order Form and Template Call Off terms);

  • 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 entitled “Approved Drug Products with Therapeutic Equivalence Evaluations” or any replacement thereof established or approved by the FDA.

  • 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 hotfix, patch or minor version update to any Platform software; and "Upgrade" means a major version upgrade of any Platform software.

  • Research record means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.

  • 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.

  • Closing of the Books Method means the apportionment of items between portions of a taxable period based on a closing of the books and records on the Distribution Date (as if the Distribution Date was the end of the taxable period), provided that any items not susceptible to such apportionment (such as real or personal property taxes imposed on a periodic basis) shall be apportioned on the basis of elapsed days during the relevant portion of the taxable period.

  • 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.

  • ORSA summary report means a confidential high-level summary of an insurer or insurance group's own risk and solvency assessment.

  • 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