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Regulatory NEWS

Defending his decision to go ahead with a U.S. Senate Health, Education, Labor and Pensions Committee hearing Tuesday on the FDA drug and device user fee agreements, Sen. Lamar Alexander stressed the importance of getting the agreements signed into law quickly.

LONDON – The EMA is standing up to defend its orphan drug legislation in the face of personalized medicines that salami slice common diseases into rare-sized subsets.

Although Seema Verma’s path through the Senate confirmation process was lined with partisan politics, a few Democrats joined their Republican colleagues to approve her as head of the Centers for Medicare & Medicaid Services on a vote of 55-43 Monday.

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