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EMA adopts EU Ombudsman recommendations to avoid bias concerns over drug approvals

EMA adopts EU Ombudsman recommendations to avoid bias concerns over drug approvals



Seeking to end another flap about transparency, the European Medicines Agency has agreed to recommendations made by the European Ombudsman to ensure that private talks with drug makers about marketing applications do not influence approval decisions.

In a Nov. 21 letter to Ombudsman Emily O’Reilly, the regulator noted it plans to separate “to the greatest extent possible” the roles of its Scientific Advisory Working Group, which makes suggestions to drug makers about such things as clinical trial design, and the members of the Committee for Medicinal Products for Human Use, which evaluates marketing applications.

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