REMS Program definition

REMS Program means the Risk Evaluation and Mitigation Program required to be implemented under Section 505-1 of the Federal Food, Drug and Cosmetic Act in connection with the regulatory approval of the Product by the FDA.
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REMS Program means the Company’s Risk Evaluation and Mitigation Strategies program for the Product Ravicti.
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REMS Program means the XYREM REMS Program, as approved by the FDA, or any successor entity thereto as approved by FDA, including successor entities including additional oxybate formulations, and as described in the REMS Documents.
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Examples of REMS Program in a sentence

  • Individuals from the REMS Program Companies (RPC) reviewing grants will include the following clinical licensures: pharmacists, nurses, physicians.

  • The first REMS assessment for the Opioid Analgesic REMS, due 6-months from the date of this letter, will include only information outlined in items 1, 2a, 2b, and 2c, and any additional information the REMS Program Companies (RPC) deems necessary to describe REMS implementation.

  • This shared system, now known as the Opioid Analgesics REMS Program, includes the products listed on the FDA REMS website, available at https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm Other products may be added in the future if additional NDAs or ANDAs are approved.

  • The Lemtrada REMS Program, a comprehensive risk management program with frequent monitoring, is being implemented to help mitigate the serious risks associated with the medications use.

  • Requiring healthcare providers who prescribe mifepristone to be certified in the Mifepristone REMS Program.

  • Because of the risk of severe neutropenia, VERSACLOZ is available only through a restricted program under a Risk Evaluation Mitigation Strategy (REMS) called the Clozapine REMS Program [see Warnings and Precautions (5.2)].Orthostatic Hypotension, Bradycardia, SyncopeOrthostatic hypotension, bradycardia, syncope, and cardiac arrest have occurred with clozapine treatment.

  • This shared system REMS Program currently includes the products listed on the FDA REMS website, available at http://www.fda.gov/rems.

  • Lemtrada® is only available in the US through a restricted program called the Lemtrada® Risk Evaluation and Mitigation Strategy (REMS) Program.

  • The present report on the Goals tracks the subregion’s global performance in achieving the 2030 Agenda for Sustainable Development, with a focus on Goal 2, in particular food security and sustainable agriculture.

  • Prescribers must enroll in the Clozapine REMS Program to prescribe for any other patients.


More Definitions of REMS Program

REMS Program means the XYWAV and XYREM REMS Program, as approved by the FDA, or any successor entity thereto as approved by the FDA, including successor entities including additional oxybate formulations, as described in the REMS Documents.
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REMS Program means the XYREM REMS Program, as approved by the FDA, and as described in the XYREM REMS Documents. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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REMS Program means the Company’s Risk Evaluation and Mitigation Strategies program for the Product Ravicti. “Services” has the meaning set forth in Section 5(b).
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REMS Program means the Risk Evaluation and Mitigation Strategy required to be implemented under Section 505-1 of the FFDCA in connection with the Regulatory Approval of the Product by the FDA.
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REMS Program means a Risk Evaluation and Mitigation Strategy Program according to the FDA Amendments Act of 2007 (FDAAA).
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Related to REMS Program

  • AML Program has the meaning ascribed thereto in Schedule 2.1(F)(8) hereof.

  • Educational program means a program for educating and preparing physician assistants which is approved by the board.

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • Education program means any program that is principally engaged in the provision of education, including, but not limited to, early childhood education, elementary and secondary education, postsecondary education, special education, job training, career and technical education and adult education, and any program that is administered by an educational agency or institution.

  • E-Verify Program above means the employment verification program administered by the United States Department of Homeland Security, the Social Security Administration, or any successor program.

  • Pilot program means a program using a representative sample of residential and small commercial customers to assist in developing and offering customer choice of electricity supply for all residential and commercial customers.

  • Program means the statutorily authorized activities of the System Agency under which this Contract has been awarded.

  • CRAF Program means the Civil Reserve Air Fleet Program authorized under 10 U.S.C. Section 9511 et seq. or any similar or substitute program under the laws of the United States.

  • Marketing Plan means a plan or system concerning a material aspect of conducting business. Indicia of a marketing plan include any of the following:

  • Prescription monitoring program means the electronic system within the Department of Health Professions that monitors the dispensing of certain controlled substances.

  • the Programme means the Government programme for delivery of smart metering in Great Britain. The Programme is responsible for overseeing the development and implementation of policy, including establishing the commercial and regulatory framework to facilitate the roll-out;

  • Training program means an NCA-approved Iowa college, the Iowa law enforcement academy or an Iowa hospital approved by the department to conduct emergency medical care training.

  • Number of Students Who Began the Program means the number of students who began a program who were scheduled to complete the program within 100% of the published program length within the reporting calendar year and excludes all students who cancelled during the cancellation period.

  • Loan Program means the State Treasurer’s Interest-Free Loan Program for Colorado School Districts authorized pursuant to the Loan Program Statutes.

  • Flexi Plan means any individual indemnity hospital insurance plan under the VHIS framework with enhancement(s) to any or all of the protections or terms and benefits that the Standard Plan provides to the Policy Holder and the Insured Person, subject to certification by the Government. Such plan shall not contain terms and benefits which are less favourable than those in the Standard Plan, save for the exception as may be approved by the Government from time to time.

  • Number of Students Who Began Program means the number of students who began the program who are scheduled to complete the program within the reporting calendar year.

  • Service program or “service” means any medical care ambulance service or nontransport service that has received authorization by the department.

  • Program services means services that include all of the following provided they are pursuant to a program agreement: program needs assessment and development, job task analysis, curriculum development and revision, instruction, instructional materials and supplies, computer software and upgrades, instructional support, administrative and student services, related school to career training programs, skill or career interest assessment services and testing and contracted services.

  • Medical Reimbursement Programs means a collective reference to the Medicare, Medicaid and TRICARE programs and any other health care program operated by or financed in whole or in part by any foreign or domestic federal, state or local government.

  • Qualifying Educational Program means a program at a post-secondary school level of not less than three consecutive weeks duration that requires each student taking the program to spend not less than 10 hours per week on courses or work in that program.

  • Individualized education program or “IEP” means a written statement for a child with a disability as defined in 14 DE Admin. Code 922.

  • Program Staff means an employee or individual who by contract with the program provides a service and has the applicable competencies, qualifications, or certification required to provide the service.

  • Procurement Plan means the Recipient’s procurement plan for the Project, dated April 2, 2010, and referred to in paragraph 1.16 of the Procurement Guidelines and paragraph 1.24 of the Consultant Guidelines, as the same shall be updated from time to time in accordance with the provisions of said paragraphs.

  • New jobs training program or “program” means the project or projects established by a community college for the creation of jobs by providing education and training of workers for new jobs for new or expanding industry in the merged area served by the community college. The proceeds of the certificates, as authorized by the Act, shall be used only to fund program services related to training programs made necessary by the creation of new jobs.

  • Basic health plan model plan means a health plan as required in RCW 70.47.060(2)(e).