MMS Holdings Expert Insights Blog

Experts at MMS share their insights on trending
topics in the pharmaceutical industry.

FDA REMS Programs, Considerations, and Compliance

FDA REMS Programs, Considerations, and Compliance

The Food and Drug Administration (FDA) Amendments Act of 2007 authorized the FDA to require a Risk Evaluation and Mitigation Strategy (REMS) Program. The REMS program is required if it is determined that specific safety measures are needed to ensure that a drug’s...

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New 2023 FDA Guidance on REMS: What’s New?

New 2023 FDA Guidance on REMS: What’s New?

The Risk Evaluation Mitigation Strategy (REMS) is a drug safety and risk management program established in 2007 by the U.S. Food and Drug Administration (FDA). Under the program, FDA might require manufacturers to implement specific safety measures for certain...

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