Beyond Labeling: How the FDA Ensures Drug Safety

In 2007, a new law was passed that gave the FDA new authorities and responsibilities to enhance drug safety. It's called the Food and Drug Administration Amendments Act and one of its provisions gave the FDA the authority to require a Risk Evaluation and Mitigation Strategy, also called REMS, from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. 

REMs may be required by the FDA as part of the approval of a new product, or for an approved product when a new safety information arises. Essentially, it is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use.

Since its launch, stakeholders have complained that the materials and requirements of REMS are not communicated clearly and consistently and they spend too much time trying to understand and comply with all the different REMS requirements.   So, this year, the FDA launched 5 guidances they hope will help resolve some of these issues and aid in how REMS systems and template documents are organized and utilized.

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List and link of new REMS guidances

  1. Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry link
  2. FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary link
  3. Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling link
  4. Format and Content of a REMS Document Guidance for Industry link
  5. Use of a Drug Master File for Shared System REMS Submissions link


The “4 W’s” of REMS

We thought it would help to provide a quick rundown on how RMS information is organized in the new REM document templates and on the REMS@FDA website.  


Who: The participant who must meet the REMS requirement.

Example: prescriber, dispenser, health care setting


When: A particular stage in the treatment or medication use process around which REMS activities needs to occur.

Example: certification, prescribing, dispensing, administration


What: A clinical or administrative activity that must be performed as part of the REMS

Example: counseling a patient, completing an enrollment form, lab testing


With what: Approved REMS material with which the requirement is carried out.

Example: Enrollment form, medication guide, educational pamphlet


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