The first stage of REMS implementation from March 2008 until December 2009 was relatively easy. FDA and drug sponsors leaqrned how to adapt existing communications programs and techniques to deliver new safety messages. Now both the agency and the sponsors are moving into new territory: evaluating REMS. Both are grappling with the challenge of how to show that programs are working.
Cole Werble
FDA's initial efforts to impose post-marketing controls on drug sponsors under the Food & Drug Administration Amendments Act were surprisingly...
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The European Medicines Agency’s ongoing pilot to streamline drug reviews by allowing companies to voluntarily pre-fill factual data in assessment report templates appears to add significant workload for industry, without delivering clear value to regulators.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Suddenly the leadership changes at the US FDA’s Center for Biologics Evaluation & Research have begun to feel like a soap opera. That is not a recipe for regulatory predictability.
The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.
After an Aug. 6 safety labeling change, the FDA became aware of “more compelling evidence” that the risk for serious chikungunya-like illness is not limited to older adults, CBER Director Prasad said.
Generic drug industry representatives applauded the FDA decision to bring back key staff in the Office of Generic Drugs that were laid off earlier this year.
The White House is directing the Health and Human Services Department to replenish stockpiles of active pharmaceutical ingredients for “especially critical” medicines.
