FDA Issues Draft Guidance on Risk Evaluation, Mitigation Strategies

The Food and Drug Administration recently announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies (REMS), titled "Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications," which are required for certain drugs or biologics.

The Food and Drug Administration Amendments Act of 2007 granted the FDA the authority to require the submission and implementation of a REMS if the FDA determines a REMS is necessary to ensure that a drug’s benefits outweigh its risks.

REMS components include medication guides; patient package inserts; a communication plan for health care providers; elements to ensure safe use including requirements for those who prescribe, dispense, or use the drug; and a timetable for REMS submission.

The draft guidance:

  • provides FDA's current thinking on the format and content that industry should use for submissions of proposed REMS
  • describes each potential element
  • includes preliminary information on the content of assessments and proposed
  • modifications of approved REMS
  • describes REMS policies for certain regulatory situations
  • informs industry about who to contact within FDA about a REMS
  • indicates FDA Web sites where documents about approved REMS will be posted
  • provides an example of what an approved REMS might look like for a fictitious product.

"With this new guidance, manufacturers will have a useful blueprint for how to develop these important safety strategies," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research.

The draft guidance is available here.

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • The Top 5 Safety and Technology Trends to Watch

    Get the latest on trends you can expect to hear more about in 2019, including continued growth of mobile safety applications, wearable technology, and smart PPE; autonomous vehicles; pending OSHA recordkeeping rulemaking; and increased adoption of international safety standard, ISO 45001.

  • Analyze Incident Data

    Collect relevant incident data, analyze trends, and generate accurate regulatory reports, including OSHA 300, 300A, and 301 logs, through IndustrySafe’s extensive incident reporting and investigation module.

  • Safety Training 101

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We’ve put together a guide on key safety training topics, requirements for certifications, and answers to common training questions.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Industry Safe
comments powered by Disqus

OH&S Digital Edition

  • OHS Magazine Digital Edition - January 2019

    January / February 2019

    Featuring:

    • PREVENTING ERRORS
      Production vs. Safety 
    • EMERGENCY SHOWERS & EYEWASH
      Meeting the Requirements for Emergency Equipment
    • CONSTRUCTION SAFETY
      The State of Contractor Safety
    • FOOT PROTECTION
      The Three Keys to Effective Chemical Management
    View This Issue