FDA Regulated definition

FDA Regulated means fall under the governance of US Food and Drug Administration regulations and guidance.
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FDA Regulated means any study that is subject to review by the U.S. Food and Drug Administration (FDA). FDA-regulated studies include all research studies that involve an Investigational New Drug (IND or BB-IND) or an Investigational Device Exemption (IDE). In addition, FDA-regulated studies include all research studies evaluating the safety and/or efficacy of drugs or devices for which an IND, BB-IND or IDE is not required.
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FDA Regulated means that study is subject to one or more FDA regulations or covered by FDA-related guidance, whether or not the study involves use of a medical device. For example, a study that does not involve a medical device, a study that involves a medical device for which the device’s safety or effectiveness is not be evaluated, or a study that involves a medical device for which FDA IDE clearance or approval is not required or has been granted, may still be subject to other FDA regulations if the study involves use or investigation of a drug or a dietary supplement, if a serious adverse event occurs during the study that requires reporting to the FDA, labeling requirements for any medical device, and post-marketing surveillance. Many other requirements may apply. Visit this FDA web page for additional information about FDA regulations: https://www.fda.gov/regulatory-information/fda-rules-and-regulations. Regardless of IDE regulatory outcome, Institutional Review Board (IRB) review is always required IAW applicable federal laws and FSU policies.
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Examples of FDA Regulated in a sentence

  • Yes No If yes, see the "Drugs, Devices, and Other FDA Regulated Products" section under Study Submission Guidance on our website.

  • See also Center for Science in the Public Interest, “Building a Modern Food Safety System for FDA Regulated Foods,” May 2009.

  • All data will also be maintained in consistency with the FDA Privacy Act System of Records #09-10-0009 (Special Studies and Surveys on FDA Regulated Products).

  • The CTO also administers the Research Pharmacy (RP), the Investigational New Drug (IND)/Investigational DeviceExemption (IDE) Assistance Program (IAP), the Clinical Trials Monitoring Assistance Program for FDA Regulated Human Subjects Research (CTMAP), Clinical Research Coordinator Training (CRCT), and the Spanish Translation Center (STC).

  • Amendment #1 to Purchase of Service Agreement between Dauphin County (MH/ID) and Lawrence Vuxta.

  • Outreach is essential to ensure that consumers and food safety partners have the information needed to make informed decisions.Provide Outreach and Education on FDA Regulated ProductsFDA strives to provide consumers with material about healthy choices using the most up-to-date science.

  • Draft Guidance for Industry: Considering Whether an FDA Regulated Product Involves the Application of Nanotechnology 2011.

  • Therefore, there is no assurance that the Company can realize liquidity for such investments in a timely manner, if at all.

  • The investigation to be undertaken is an FDA Phase I, II, III, or IV drug study or an FDA- Regulated Medical Device Study.

  • StewardshipFDA’s core mission goals and objectives are:Goal 1: Enhance Oversight of FDA Regulated ProductsGoal 2: Improve and Safeguard Access to FDA Regulated Products to Benefit HealthGoal 3: Promote Better Informed Decisions about the Use of FDA Regulated ProductsGoal 4: Strengthen Organizational Excellence and AccountabilityThis framework is meant to be interpreted appropriately for each program area and regulated product.


More Definitions of FDA Regulated

FDA Regulated means research involving human subjects where one of the purposes of the study is to evaluate the safety and/or efficacy of a drug/device/biologic, regardless of whether or not the study is being conducted under an IND/IDE/BB-IND. Please be reminded that software algorithms developed with the intent to influence therapeutic decisions or clinical care may be considered devices under FDA regulations.
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Related to FDA Regulated

  • PDMA means the Prescription Drug Marketing Act of 1987, as amended from time to time, together with any rules or regulations promulgated thereunder.

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

  • 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.

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

  • 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.

  • EEA Regulated Market means a market as defined by Article 4.1(14) of Directive 2004/39/EC of the European Parliament and of the Council on markets on financial instruments;

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

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

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • Dangerous drug means any of the following:

  • Health and Safety Plan means a documented plan which addresses hazards identified and includes safe work procedures to mitigate, reduce or control the hazards identified;

  • Occupational Health and Safety Act means the Occupational Health and Safety Act, 1993 (Act No 85 of 1993);

  • national regulatory authority means the body or bodies charged by a Member State with any of the regulatory tasks assigned in this Directive and the Specific Directives;

  • Insurance Regulatory Authority means, with respect to any Insurance Subsidiary, the insurance department or similar Governmental Authority charged with regulating insurance companies or insurance holding companies, in its jurisdiction of domicile and, to the extent that it has regulatory authority over such Insurance Subsidiary, in each other jurisdiction in which such Insurance Subsidiary conducts business or is licensed to conduct business.

  • 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.

  • 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.

  • Rail Safety Act means the Rail Safety Act 1998 (WA);

  • Market Abuse Regulation means Regulation (EC) No …/… of the European Parliament and of the Council on insider dealing and market manipulation (market abuse);

  • Nuclear Regulatory Commission (NRC) means the U.S. Nuclear Regulatory Commission or its duly authorized representatives.

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

  • FDA Act means the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the rules and regulations promulgated thereunder.

  • HITECH Act means the Health Information Technology for Economic and Clinical Health Act, TitleXIII, Subtitle D, Part 1 & 2 of the American Recovery and Reinvestment Act of 2009.

  • Prescription drug order means a lawful order of a practitioner for a drug or device for a specific patient that is communicated to a pharmacist.

  • NEPA refers to the National Environmental Policy Act, 42 U.S.C. §§ 4321 et seq.

  • EPA Hazardous Substance Superfund means the Hazardous Substance Superfund established by the Internal Revenue Code, 26 U.S.C. § 9507.

  • Environmental, Health and Safety Laws means the Comprehensive Environmental Response, Compensation and Liability Act of 1980, the Resource Conservation and Recovery Act of 1976, and the Occupational Safety and Health Act of 1970, each as amended, together with all other laws (including rules, regulations, codes, plans, injunctions, judgments, orders, decrees, rulings, and charges thereunder) of federal, state, local, and foreign governments (and all agencies thereof) concerning pollution or protection of the environment, public health and safety, or employee health and safety, including laws relating to emissions, discharges, releases, or threatened releases of pollutants, contaminants, or chemical, industrial, hazardous, or toxic materials or wastes into ambient air, surface water, ground water, or lands or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport, or handling of pollutants, contaminants, or chemical, industrial, hazardous, or toxic materials or wastes.