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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REMS Decision, Evaluation Guidances In Process, FDA Says
One draft guidance may be released this year outlining how FDA evaluates the risk-management programs.
FDA Plans Five Biosimilar, Three Social Media Draft Guidances In 2014
Additional draft guidances address implementation of the Drug Supply Chain Security Act, multiple endpoints in clinical trials, and public disclosure of FDA-sponsored studies.
REMS Communications Could Get Refreshed After Advisory Panel Meeting
FDA’s Risk Communications Advisory Committee will address methods for presenting REMS information and assessing whether it is reaching the target population.