Peter O'Donnell

Articles by Peter O'Donnell

Applied Clinical Trials

The British government and the country's squabbling parliament are still incapable of deciding when-or even if-the UK should leave the European Union, still less how.

Applied Clinical Trials

The decision of the leaders of the European Union over the weekend to endorse the Withdrawal Agreement for the UK's departure was historic in that it was the first time ever that the European Council had to face the imminent reality of a member state dropping out.

Applied Clinical Trials

The mutual recognition agreement between the European Union and the US FDA now covers 15 European countries, after Portugal won US recognition in mid-September.

Applied Clinical Trials

The workings of the European Union are notoriously complicated, with the result that misunderstanding is commonplace, even among those who might like to know more about it.

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The late-June announcement that Ireland is joining the Beneluxa Initiative on Pharmaceutical Policy might suggest renewed vigour for the drive to equip national governments with more clout in their pricing negotiations with international drug firms.

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On Europe Day, the agency itself is right now keener than ever to assess its worth and the value of its services to Europe and to Europeans.

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The British government continues to offer guarantees and reassurances about the post-Brexit future of its life-sciences sector despite the obvious failure so far to get even close to negotiating a withdrawal agreement with the EU.

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Renewed attempts in the United States to win legislative approval for the right-to-try concept have again focused attention on that inevitably grey area between hoping a new medicine is going to be effective and demonstrating that it can be.

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The rare disease community in Europe has come out fighting to defend its record-and its future-in the face of what it sees as growing threats to research.

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As the EMA celebrates its 2017 highlights, the new year brings deeper challenges for the agency-including preserving the credibility of its patient-first mission.