FDA Regulation definition

FDA Regulation means any rule, regulation or administrative order promulgated or issued by the FDA.
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FDA Regulation has the meaning ascribed to such term in Section 3.6.5.
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Examples of FDA Regulation in a sentence

  • FDA Regulation The 2018 Farm Bill did not change the FDA’s authority with respect to food or drugs.

  • The Farm Bill can be found in its entirety at http://docs.house.gov/billsthisweek/20181210/CRPT- 115hrpt1072.pdf.Table of Contents FDA Regulation The 2018 Farm Bill did not change the FDA’s authority with respect to food or drugs.

  • Any negative outlook on the industry will adversely affect our business operations.The possible FDA Regulation of hemp and industrial hemp derived CBD, and the possible registration of facilities where hemp is grown and CBD products are produced, if implemented, could negatively affect the cannabis industry generally, which could directly affect our financial conditionThe Farm Bill established that hemp containing less the .03% THC was no longer aSchedule 1 drug under the CSA.

  • The Complaint Report shall include, as applicable, an initial assessment of Medical Device Reporting (“MDR”) status (as required by the U.S. Food and Drug Administration (FDA) Regulation 21 CFR Part 803) or need for Vigilance reporting (“Vigilance”) as required by the European Union In Vitro Diagnostic Directive (“IVDD”) or the Canadian Medical Device Regulations (“CMDR”).

  • Any negative outlook on the industry will adversely affect our business operations.The possible FDA Regulation of hemp and industrial hemp derived CBD, and the possible registration of facilities where hemp is grown and CBD products are produced, if implemented, could negatively affect the cannabis industry generally, which could directly affect our financial conditionThe Farm Bill established that hemp containing less the .03% THC was no longer a Schedule 1 drug under the CSA.

  • No event has occurred and to Seller’s Knowledge no circumstances exists, and no member of the Seller Group has received notice alleging any circumstance or condition that (with or without the passage of time or the giving of notice) may result in a violation of, conflict with or failure to conduct the Business in compliance with, any applicable Law, FDA Regulation, FDA Authorizations and ISO Requirements.

Related to FDA Regulation

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

  • 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.

  • 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.

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

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

  • Council Regulation means Council Regulation (EC) No. 2100/94 of 27th July 1994 on Community plant variety rights;

  • the Council Regulation means Council Regulation (E.C.) No. 2201/2003 of 27th November 2003 on jurisdiction and the recognition and enforcement of judgments in matrimonial matters and matters of parental responsibility;

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

  • 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.

  • 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.

  • Market Abuse Regulation means the EU Market Abuse Regulation (596/2014).

  • Data Protection Regulation means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 20161 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation);

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

  • WHFIT Regulations Treasury Regulations section 1.671-5, as amended.

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

  • SRM Regulation means Regulation (EU) No 806/2014 of the European Parliament and Council of 15 July 2014 establishing uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms in the framework of a Single Resolution Mechanism and a Single Resolution Fund and amending Regulation (EU) No 1093/2010, as amended or replaced from time to time.

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