FDA Law and Regulation definition

FDA Law and Regulation means the provisions of the FD&C Act and all applicable regulations promulgated by the FDA.
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FDA Law and Regulation has the meaning set forth in Section 4.28(a).
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FDA Law and Regulation means the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. §§ 301 et seq., and all applicable regulations promulgated by the FDA, including but not limited to the recordkeeping provisions of the FDA’s Medical Device Reporting requirements as set forth in 21 C.F.R. Part 803, as applicable.
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Examples of FDA Law and Regulation in a sentence

  • Neither the Company nor any of the Subsidiaries has entered into any consent decree or other Order pursuant to any FDA Law and Regulation.

  • Except upon the prior written consent of the Insurer which consent shall not unreasonably be withheld, the Issuer shall not allow the transfer, modification or amendment, nor consent to any transfer, modification or amendment of the Certificate of Trust unless such amendment is required under the Delaware Business Trust Act.

  • There is no civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter or proceeding pending against the Company and the Company has no liability (whether actual or contingent) for failure to comply with any FDA Law and Regulation.

  • The Company has complied in all material respects with all notification and reporting requirements applicable to the export requirements of the FDA Law and Regulation.

  • The overall need therefore is four AGPs to accommodate all demand, which includes some spare capacity for growth.

  • All Products that have been exported from the United States by the Company have been exported in compliance in all material respects with the applicable export requirements of the FDA Law and Regulation.

  • The Company has not received any notice or communication from the FDA alleging material noncompliance with any applicable FDA Law and Regulation.

  • Since the Applicable Date, neither the Company nor any of its Subsidiaries have received any written notice or communication from the FDA or other Governmental Entity alleging noncompliance with any applicable FDA Law and Regulation or other comparable Laws.

  • The Company has not received any written notice or, to the Knowledge of Seller, other communication from the FDA or any state regulatory authority alleging noncompliance with any applicable FDA Law and Regulation.

  • There has not been any violation of any FDA Law and Regulation by the Company in its product development efforts, submissions, record keeping and reports to FDA or any state regulatory authority that would reasonably be expected to require or lead to investigation, corrective action or regulatory enforcement action.


More Definitions of FDA Law and Regulation

FDA Law and Regulation means the federal Food, Drug and Cosmetic Act (the FD&C Act), 21 U.S.C. §§ 301 et seq., as amended, and all applicable regulations promulgated by the United States Food and Drug Administration (“ FDA”), including but not limited to the recordkeeping provisions of the FDA’s Medical Device Reporting requirements as set forth in 21 C.F.R. Part 803, as applicable.
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FDA Law and Regulation has the meaning assigned to such term in Section 3.16(a).
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FDA Law and Regulation has the meaning set forth in Section 5.28.1.
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FDA Law and Regulation shall have the meaning set forth in Section 3.5(g).
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FDA Law and Regulation as defined in the preamble to Section 4.29.
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Related to FDA Law and Regulation

  • Applicable law and regulations means the Federal Credit Union Act and rules and regulations issued thereunder or other applicable federal and state statutes and rules and regulations issued thereunder as the context indicates.

  • Applicable Laws and Regulations means all duly promulgated applicable federal, State and local laws, regulations, rules, ordinances, codes, decrees, judgments, directives, or judicial or administrative orders, permits and other duly authorized actions of any Governmental Authority having jurisdiction over the relevant parties, their respective facilities, and/or the respective services they provide.

  • SAFE Rules and Regulations means collectively, the Circular 37 and any other applicable SAFE rules and regulations.

  • HIPAA Regulations means the regulations promulgated under HIPAA by the United States Department of Health and Human Services, including, but not limited to, 45 C.F.R. Part 160 and 45 C.F.R. Part 164.

  • Data Protection Laws and Regulations means all laws and regulations, including laws and regulations of the European Union, the European Economic Area and their member states, Switzerland and the United Kingdom, applicable to the Processing of Personal Data under the Agreement.

  • ISA Regulations means The Individual Savings Account Regulations 1998, as amended or replaced from time to time.

  • Sanctions Laws and Regulations means any sanctions, prohibitions or requirements imposed by any executive order (an “Executive Order”) or by any sanctions program administered by OFAC.

  • PDMA means the Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder from time to time.

  • AIFM Regulation means Commission Delegated Regulation (EU) No. 231/2013.

  • Accessibility Standards means accessibility standards and specifications for Texas agency and institution of higher education websites and EIR set forth in 1 TAC Chapter 206 and/or Chapter 213.

  • PPPFA Regulations means the Preferential Procurement Regulations, 2017 published in terms of the PPPFA.

  • Laws and Regulations means federal, state, local and foreign statutes, laws, ordinances, regulations, rules, codes, orders, constitutions, treaties, principles of common law, judgments, decrees or other requirements;

  • TUPE Regulations means the Transfer of Undertakings (Protection of Employment) Regulations 2006, as amended.

  • Legal Requirements means any federal, state, local, municipal, foreign or other law, statute, constitution, principle of common law, resolution, ordinance, code, order, edict, decree, rule, regulation, ruling or requirement issued, enacted, adopted, promulgated, implemented or otherwise put into effect by or under the authority of any Governmental Entity.

  • Medicaid Regulations means, collectively, (i) all federal statutes (whether set forth in Title XIX of the Social Security Act or elsewhere) affecting the medical assistance program established by Title XIX of the Social Security Act and any statutes succeeding thereto; (ii) all applicable provisions of all federal rules, regulations, manuals and orders of all Governmental Authorities promulgated pursuant to or in connection with the statutes described in clause (i) above and all federal administrative, reimbursement and other guidelines of all Governmental Authorities having the force of law promulgated pursuant to or in connection with the statutes described in clause (i) above; (iii) all state statutes and plans for medical assistance enacted in connection with the statutes and provisions described in clauses (i) and (ii) above; and (iv) all applicable provisions of all rules, regulations, manuals and orders of all Governmental Authorities promulgated pursuant to or in connection with the statutes described in clause (iii) above and all state administrative, reimbursement and other guidelines of all Governmental Authorities having the force of law promulgated pursuant to or in connection with the statutes described in clause (ii) above, in each case as may be amended, supplemented or otherwise modified from time to time.

  • EEA Regulations means the Immigration (European Economic Area) Regulations 2006.

  • SEBI Regulations means the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015 together with the circulars issued thereunder, including any statutory modification(s) or re-enactment(s) thereof for the time being in force.

  • UCITS Regulations means the European Communities (Undertakings for Collective

  • Applicable Technical Requirements and Standards means those certain technical requirements and standards applicable to interconnections of generation and/or transmission facilities with the facilities of an Interconnected Transmission Owner or, as the case may be and to the extent applicable, of an Electric Distributor, as published by Transmission Provider in a PJM Manual provided, however, that, with respect to any generation facilities with maximum generating capacity of 2 MW or less (synchronous) or 5 MW or less (inverter-based) for which the Interconnection Customer executes a Construction Service Agreement or Interconnection Service Agreement on or after March 19, 2005, “Applicable Technical Requirements and Standards” shall refer to the “PJM Small Generator Interconnection Applicable Technical Requirements and Standards.” All Applicable Technical Requirements and Standards shall be publicly available through postings on Transmission Provider’s internet website.

  • Repurchase Rules and Regulations shall have the meaning specified in Section 6.14 of the Indenture.

  • CDM Regulations means the Construction (Design and Management) Regulations 2015;

  • Medicare Regulations means, collectively, (a) all Federal statues (whether set forth in Title XVIII of the Social Security Act or elsewhere) affecting the health insurance program for the aged and disabled established by Title XVIII of the Social Security Act and any statues succeeding thereto and (b) all applicable provisions of all rules, regulations, manuals and orders and administrative, reimbursement and other guidelines having the force of law of all Governmental Authorities (including CMS, the OIG, HHS or any person succeeding to the functions of any of the foregoing) promulgated pursuant to or in connection with any of the foregoing having the force of law, as each may be amended, supplemented or otherwise modified from time to time.

  • Applicable Laws/ Rules means the laws/ Rules of Islamic Republic of Pakistan/Punjab, as they may be issued and enforced from time to time.

  • Land Use Regulations means all federal, state and local laws, rules, regulations, ordinances and plans relating to or governing the use or development of land in the City, including but not limited to environmental, zoning and building code laws and regulations.

  • Privacy Regulations means the Privacy and Electronic Communications (EC Directive) Regulations 2003 as amended in 2004, 2011, 2015 and 2016 and as may be further amended from time to time;

  • FHA Regulations Regulations promulgated by HUD under the National Housing Act, codified in 24 Code of Federal Regulations, and other HUD issuances relating to FHA Loans, including the related handbooks, circulars, notices and mortgagee letters.