FDA’s Hamburg Says EMA Could Be Model For Global Regulatory Coalition
This article was originally published in The Pink Sheet Daily
Outgoing commissioner urges authorities to move away “from an outdated paradigm of only working in our own jurisdiction” in speech at European Medicines Agency’s 20th anniversary meeting.
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Margaret Hamburg’s public health, as opposed to academic medicine, background was off-putting to some in pharma initially, but she’ll leave the agency in March with high drug approval numbers and significant praise for new initiatives such as the breakthrough therapy program.
In contrast to the existing inspection program for clinical trials, sites around the globe will be targeted.
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