FDA Regulations definition

FDA Regulations means any Laws relating to or administered by the FDA.
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FDA Regulations shall have the meaning ascribed to it in Section 3.1(t)(iii).
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FDA Regulations has the meaning set forth in Section 4.13(b).
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Examples of FDA Regulations in a sentence

  • University does not perform any services under this agreement that may be subject to FDA Regulations, e.g. GMP, cGMP, GLP, GCP work/services.

  • Supplier agrees that it will comply with all aspects of the FDA Regulations as detailed in Title 21 C.F.R. (Food & Drugs) § 1-1499.

  • FDA Regulations: Each exhibitor must comply with all FDA regulations.

  • B-2.01 In compliance with FDA Regulations 21 CFR Part 820.50, Purchasing Controls, Supplier shall comply with section 6.0 in the general document.

  • B-2.03 In compliance with FDA Regulations 21 CFR Part 820.65, Traceability, Supplier shall comply with 5.07 and 4.06.

  • B-2.02 In compliance with FDA Regulations 21 CFR Part 820.60, Identification, Supplier shall comply with section 2.10 in the general document.

  • Material ordered hereby is warranted to conform to applicable FDA Regulations pertaining to such material and its intended use.

  • Part II – Basic Requirements for Active Substances used as Starting Materials and ICHQ7-2017 – as incorporated in the Federal Register volume 66 No 186 and those sections applicable within the FDA Regulations 21 CFR Part 210, 211, 600, 601 and 610.

  • University does not perform any services under this Agreement that may be subject to FDA Regulations, e.g. GMP, cGMP, GLP, GCP work/services.

  • Sponsor shall be responsible for obtaining and maintaining authorization for the Clinical Trial from Health Canada in accordance with Part C, Division 5 of the FDA Regulations.


More Definitions of FDA Regulations

FDA Regulations means the Food and Drugs Regulations, C.R.C., c. 870, made under the FDA;
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FDA Regulations means the rules and regulations of the FDA, regardless of having the effect of law.
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FDA Regulations means all rules, regulations, directives, decrees, protocols, codes, guidelines, interpretations, policies, Authorizations or Laws (including the US Food Drug and Cosmetic Act and the Food and Drugs Act of Canada) issued or administered by any FDA Authority, including those relating to investigational use, investigational device exemption, premarket notification, premarket approval, approval, 501(k) clearance, good clinical and good laboratory practices, good manufacturing practices, record keeping, filing of reports, packaging, labeling, testing, advertising, problem and complaint investigations and handling, and patient medical record security.
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Related to FDA Regulations

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

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

  • 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.

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

  • 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.

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

  • EP Regulations means The Environmental Permitting (England and Wales) Regulations SI 2016 No.1154 and words and expressions used in this permit which are also used in the Regulations have the same meanings as in those Regulations.

  • the 2000 Regulations means the Water Supply (Water Quality) Regulations 2000(b); "the 2001 Regulations" means the Water Supply (Water Quality) Regulations 2001(c);

  • FHA Regulations means the regulations promulgated by the Department of Housing and Urban Development under the National Housing Act, as amended from time to time and codified in 24 Code of Federal Regulations, and other Department of Housing and Urban Development issuances relating to FHA Loans, including the related handbooks, circulars, notices and mortgagee letters.

  • UCITS Regulations means the European Communities Undertakings for Collective Investment in Transferable Securities) Regulations, 2011 (S.I. No. 352 of 2011) (as amended consolidated or substituted from time to time) and any regulations or notices issued by the Central Bank pursuant thereto for the time being in force.

  • SBE Regulations means the written regulations and procedures adopted pursuant to this chapter for procurement of Supplies, Services and Public Works.

  • CFTC Regulations means the rules and regulations promulgated by the CFTC, as amended.

  • the 1997 Regulations means the Zebra, Pelican and Puffin Pedestrian Crossing Regulations 1997.

  • FCC Regulations means the regulations duly and lawfully promulgated by the FCC, as in effect from time to time.

  • EU Regulation means a regulation within the meaning of Article 288 of the Treaty on the Functioning of the European Union;

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

  • Radio Regulations means the Radio Regulations annexed to, or regarded as being annexed to, the most recent International Telecommunication Convention which may be in force at any time.

  • the 2007 Regulations means the Civil Enforcement of Parking Contraventions (England) General Regulations 2007;

  • the 2001 Regulations means the Water Supply (Water Quality) Regulations 2001[63];

  • TRADES Regulations means the regulations of the United States Department of the Treasury, published at 31 C.F.R. Part 357, as amended from time to time. Unless otherwise defined herein, all terms defined in the TRADES Regulations are used herein as therein defined.

  • 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;

  • Conduct Regulations means the Conduct of Employment Agencies and Employment Businesses Regulations 2003;

  • General Regulations means the Charitable Incorporated Organisations (General) Regulations 2012.

  • OHS Regulation means the Workers Compensation Act (British Columbia), including without limitation, the Occupational Health & Safety Regulation (BC Regulation 296/97, as amended by BC Regulation 185/99) enacted pursuant to such Act, all as such Act or Regulations are amended or re-enacted from time to time.

  • These regulations means 9VAC5-10 (General Definitions) through 9VAC5-80 (Permits for Stationary Sources).