REMS definition

REMS means Risk Evaluation and Management Strategies approved by the FDA.

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REMS means a risk evaluation and mitigation strategy which is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

REMS means, in the United States, a risk evaluation and mitigation strategy required by the FDA under the authority granted to it in 28 U.S.C. § 355-1, and in the European Union, a risk management plan as described in the EMA’s Guideline on Risk Management Systems for Medicinal Products for Human Use (2005).

Examples of REMS in a sentence

• 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.

• The Pharmacy and REMS Pharmacy Services (collectively, the “Services”) to be provided as of the Effective Date are described in written Work Orders hereunder.

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

• ESSDS shall ensure that all employees assigned to support the REMS Pharmacy Services are qualified and competent in their respective roles and responsibilities and have reasonable experience performing the tasks they will perform in connection with the REMS Pharmacy Services, consistent with industry standards.

• ESSDS shall provide the REMS Pharmacy Services through personnel who are qualified and appropriately trained to provide the REMS Pharmacy Services (the “Personnel”).

More Definitions of REMS

REMS means risk evaluation and mitigation strategy.

REMS has the meaning set forth in Section 4.4.

REMS means a Risk Evaluation Mitigation Strategy.

REMS has the meaning set forth in Section 2.1(f).

REMS means a risk evaluation and mitigation strategy;

REMS means the Risk Mitigation and Evaluation Strategy required by FDA for the Products under Title IX of the Food and Drug Administration Amendment Act of 2007.

REMS shall have the meaning set forth in Section 6.01.