New packaging solutions for life sciences, all at PACK EXPO in Chicago
Discover new packaging solutions from hundreds of suppliers specializing in life sciences, all under one roof at PACK EXPO International in Chicago.

FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategies*

The U.S. Food and Drug Administration today announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies or REMS, which are required for certain drugs or biologics.

The Food and Drug Administration Amendments Act of 2007 (FDAAA) 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The draft guidance for industry titled “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications”:

* 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 the FDA's Center for Drug Evaluation and Research.

The draft guidance is available at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf
Explore new technology from hundreds of life sciences suppliers.
At PACK EXPO International, you’ll find innovations from hundreds of exhibitors that specialize in pharmaceuticals, biologics, nutraceuticals, medical devices and more. No other show delivers as many solutions to keep your products safe and effective.
Read More
Explore new technology from hundreds of life sciences suppliers.
New food packaging & processing solutions, all at PACK EXPO in Chicago
Experience the cutting edge of food packaging and processing innovation at PACK EXPO International this November. See machinery and equipment in action, discover new technologies, and learn sustainable solutions from experts, all in one place.
Read More
New food packaging & processing solutions, all at PACK EXPO in Chicago