FDA Decreases REMS Changes Burden

Monday, April 13, 2015

Source: FDA News

Drugmakers can now make minor changes to drug safety assurance plans without waiting for FDA approval, reducing some of the burden of managing risk evaluation and mitigation strategies.

In draft guidance released last week, the FDA defines three types of REMS changes — minor revisions, minor modifications and major modifications — and explains the process by which pharma companies can make these changes as well as timelines for the agency’s responses.

The law allowing the new classifications, the 2012 FDA Safety and Innovation Act, has been on the books for more than two-and-a-half years, but drugmakers haven’t been able to take advantage of the policy due to the lack of FDA guidance.

Minor revisions, the lowest classification, include editorial changes, typo corrections and changes to the application holder's name or address. Such changes, which won’t affect the risk message or other requirements, should be submitted to the agency and documented in the next REMS annual report required for the drug, the FDA says. Other examples of minor revisions include changing a drug name or changing the signatory for a Dear Health Care Provider Letter that is part of the REMS communication plan materials.

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