Rasi At The EMA: Redefining Benefit/Risk As Staggered Approvals Rise
The Executive Director of the European Medicines Agency Guido Rasi’s dual goals of increasing safety and overall accountability undoubtedly will benefit patients and industry alike, but a grueling task lies ahead.
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InterMune, AbbVie Data Case Could Add Fuel To Wider European Disclosure Debates
In an interim judgment, the General Court of the European Union has stopped Europe’s top drug regulator from releasing trial data on Esbriet and Humira until it makes a final decision on access to such documents.
Europe Transparency Initiatives May Aid Progress Toward Adaptive Licensing Systems
Industry and regulators are showing more interest in implementing adaptive licensing in Europe. Both sides agree that increased trust and transparency could be stepping stones towards this goal.
EU Health Commissioner Candidate Remains Question Mark For Pharma
The European Parliament has voted in favor of Maltese Foreign Minister Tonio Borg’s candidacy for the vacant EU health commissioner post despite his lack of health policy experience.