REMS Modification Studies Could Use Foreign Markets As Controls
A look at the safety record of a drug in foreign countries where REMS elements are not in play could differentiate the impact of a REMS compared to other risk management efforts, Amgen suggests.
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One draft guidance may be released this year outlining how FDA evaluates the risk-management programs.
Additional draft guidances address implementation of the Drug Supply Chain Security Act, multiple endpoints in clinical trials, and public disclosure of FDA-sponsored studies.
FDA’s Risk Communications Advisory Committee will address methods for presenting REMS information and assessing whether it is reaching the target population.