By Ramsey Baghdadi
Ask someone what’s wrong with FDA and you’re likely to get two completely opposite answers: the agency is either being...
Getting it Right on Drug Safety: FDA Makes its Case
FDA has become everyone's favorite punching bag. But the agency's elder statesman says FDA is getting it right when it comes to the issue of drug safety.
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The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.
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New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.
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Pink Sheet reporter and editors discuss the potential impact George Tidmarsh could have as director of the US FDA Center for Drug Evaluation and Research and the issues threatening the future of Sarepta’s gene therapy Elevidys.
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The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
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The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
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The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
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The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.