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Latest From Drug Safety
Dutch regulator Sabine Straus will take over as chair of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee when the UK’s June Raine leaves the post this year.
US FDA's Woodcock tells the Pink Sheet that goals include eliminating duplication through creation of one safety review process.
Stada and Accord are among the companies affected by an EU wide recall of valsartan manufactured by a Chinese supplier.
US court orders firms to release information on all opioid products ever classified as Schedule II from one year prior to launch date; government, manufacturers oppose public disclosure of DEA distribution data.
Pain Therapeutics CEO Barbier says comparing Remoxy to Endo's withdrawn Opana ER 'borders on slanderous' and asserts that after three complete response letters, FDA is once again moving goalposts for approval.
Agency is paying “enormous sums” to access postmarket information from payers, Commissioner Gottlieb says, suggesting public-private partnerships to enhance access.
FDA’s Sharon Hertz opened up an advisory committee review of PTI’s proposed abuse-deterrent formulation of Remoxy by remarking on the absence of data about the real-world impact of approved ADFs. That doesn’t have much to do with Remoxy – which appears headed to yet another rejection – but it is an important message for other sponsors of opioid therapies to heed.
The European Medicines Agency has updated its guidance on Brexit to offer companies more advice on the regulatory changes they will need to make in areas like transfers of MAs, rapporteurships and orphan designations, multi-country packs, and Article 58 opinions.
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