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Risk Evaluation and Mitigation Strategies Guidance for Pharmaceutics and Biologics

BayBiotech.NET




FDA has posted draft guidance for Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications on its website. The draft guidance has been posted in September 2009 and is open for comments and feedbacks from all that may have an interest
in the subject.
In a nutshell, the guidance authorizes FDA to require the applicants of NDA (new drug applications), ANDAs (abbreviated new drug applications), and biologics license applications (BLAs) to submit a proposed
Risk Evaluation and Mitigation Strategies (REMS) within 180 days once notified by FDA and may come to the applicant, if FDA becomes aware that such a strategy might be necessary to ensure that the benefits of the drug outweigh the risks of the drug in question.
Before September 2007, when the Food and Drug Administration Amendments Act of 2007 (FDAAA) was signed, FDA used to approve a small number of drug and biological products with risk minimization action plans (RiskMAPs) that was considered to be a strategic safety program designed to meet specific goals and objectives in minimizing known risks of a product while preserving its benefits.
RiskMAPs were developed for products that had risks that required additional risk management strategies beyond describing the risks and benefits of the product in labeling and performing required safety reporting.

Since now FDAAA has given FDA the authority to require REMS when necessary to ensure that the benefits of a drug outweigh the risks, if FDA determines even after approval of the product, that a REMS is necessary even if the drug had satisfied the RiskMAP requirements, the involved party may have to submit REMS plans if notified by the agency.
Although, there are number of overlaps that eventually will be carried over from RiskMAPs to REMS,
to further understand the details of the expected content of REMS submission, follow the link provided here:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf

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