Tag Archive: REMs

Clinical Trials & REMS in the Time of Corona: FDA & MHRA Advice and Guidance

Pharmacovigilance expert Bart Cobert discusses the FDA and MHRA guidance for non-Corona related clinical trials.

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Bart’s Corner: FDA’s New REMS Guidance

In April, FDA released a final guidance on Risk Evaluation and Mitigation Strategies (REMS): Modifications & Revisions. The title is a bit of a misnomer. This is not really a modification or revision of the big issues involved with REMS creation and implementation, but rather gives guidance to companies that[…]

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Bart's Corner: REMS Update

Bart’s Corner: REMS Update

In September 2014 FDA issued a paper on Standardizing & Evaluating Risk Evaluation and Mitigation Strategy (REMS). A REMS is put in place for those products to ensure that benefits outweigh the risks. REMS may require additional measures above and beyond the usual post-marketing safety surveillance by the sponsor. This[…]

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Bart’s Corner: Update on EMA Risk Management Plans (RMPs)

In April of this year the EMA announced the first public summary of an RMP, in this case for the drug Neuraceq [florbetaben (18F)] The EMA also published an update of their webpage on RMPs, which noted that the revision to the Good PV Practice RMP module – Module V[…]

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