FDA Unveils Risk Strategies For Drug Industry

Law360, New York (October 1, 2009, 3:25 PM EDT) -- The U.S. Food and Drug Administration on Wednesday issued the first draft guidance for the pharmaceutical industry on risk evaluation and mitigation strategies that are required for certain drugs and biologics.

The guidance was issued under the Food and Drug Administration Amendments Act of 2007, which gave the agency the authority to require the submission and implementation of a risk evaluation and mitigation strategy, or REMS, if it determines such a strategy is necessary to ensure that a drug’s benefits outweigh its risks.

Under the FDAAA,...
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