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 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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REMS Program means the Company’s Risk Evaluation and Mitigation Strategies program for the Product Ravicti.
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Examples of REMS Program in a sentence

  • ESSDS shall furnish and maintain a suitable place for storage of REMS Program Items.

  • ESSDS is strictly prohibited from selling, utilizing, or transferring REMS Program Items to any third-party under any circumstances not contemplated by this Agreement.

  • From the Effective Date of this Agreement, Jazz Pharmaceuticals shall provide REMS Program Items to ESSDS of the type and quantities to be reasonably determined by Jazz Pharmaceuticals for performance of REMS Pharmacy Services.

  • ESSDS shall not utilize or distribute REMS Program Items for any purpose other than as set forth in this Agreement and the Work Orders hereunder.

  • REMS Program Items shall be marked as property of Jazz Pharmaceuticals.

  • Legal title to all REMS Program Items shall remain with Jazz Pharmaceuticals.

  • If a Product is subject to a REMS Program, the parties will meet and negotiate in good faith regarding Distributor’s compliance with the REMS Program, the costs of such compliance, and any adjustment to the services fees payable under this Agreement to cover any such costs.

  • What is the most important information I should know about FILSPARI?• FILSPARI is only available through the FILSPARI REMS Program.

  • US Bio shall distribute Product, perform the Hub Services, and otherwise conduct all activities under this Agreement in accordance with the REMS Program and any additional policies Dyax implements and provides in writing to US Bio.

  • In connection with the provision of Services, ESSDS shall at all times handle, maintain, store, transport and deliver the Product in accordance with all Applicable Laws and SOPs. ESSDS will prepare the Product under conditions that are consistent with currently accepted standards of care including relevant requirements specified in the applicable SOPs and Work Instructions, the REMS Program, and Product Prescribing Information.


More Definitions of REMS Program

REMS Program means a Risk Evaluation and Mitigation Strategy Program according to the FDA Amendments Act of 2007 (FDAAA).
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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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Related to REMS Program

  • PEBB program means the program within the HCA that administers insurance and other benefits for eligible employees (as described in WAC 182-12-114), eligible retired employees (as described in WAC 182-12-171 and 182-12-180), eligible survivors (as described in WAC 182-12-180, 182-12-250, and 182-12-265), eligible dependents (as de- scribed in WAC 182-12-250 and 182-12-260) and others as defined in RCW 41.05.011.

  • 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 the pilot program identified and funded through the Funding Agreement and described in that Funding Agreement and its attachments.

  • 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 has the meaning set forth in Section 4.3(a).

  • Educator preparation program means a planned sequence of academic courses and experiences leading to a recommendation for licensure by the State Board.

  • Prescription monitoring program or "PMP" means the Wash- ington state prescription monitoring program authorized under chapter

  • the Programme means the programme leading to the Degree of Master of Laws – LL.M – in International Maritime Law;

  • 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.

  • 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 and any other non-government funded third party payor programs.

  • Wellness program means a program offered by an employer that is designed to promote health or

  • 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 a person employed by the local program who is knowledgeable in a particular subject matter. For the purposes of the complaint process, program staff may not be involved in a specific complaint prior to the receipt of the complaint or the request for a review of the complaint.

  • 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.