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Califf Closes In On Reprising His FDA Role After Senate Committee Hearing

 
• By Brian Bossetta

After a mostly friendly round of questioning from members of the US Senate committee on health, the confirmation of President Joe Biden’s pick to lead the US FDA seems more likely.

Califf and covid (Nielsen Hobbs; the Pink Sheet | Getty and Shutterstock images)

Robert Califf took another step toward getting back in the ring as commissioner of the Food and Drug Administration after fielding questions from members of the Senate’s Health, Education, Labor and Pensions Committee (HELP) committee on Tuesday, 14 December.

President Joe Biden has tapped Califf to take the reins of the agency from acting commissioner Janet Woodcock. Califf spent...

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• By Ashley Yeo

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Expert Panels Remain Tough On Manufacturers And Their Notified Bodies

 
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The EU’s extra layer of checks on clinical evidence is proving a difficult, and sometimes humiliating process, for many device companies whose products have come under the spotlight.

FDA Document Request Denied As Case Against SurModics Merger Intensifies

 
• By Elizabeth Orr

A federal court in Illinois ruled against SurModics and BC Holdings' request for FDA documents to support a proposed merger. The FTC has challenged the merger, claiming it threatens competition in hydrophilic device coatings. The ruling may indicate the FTC is likely to succeed.

EU Authorities Unite In Call For Urgent Overhaul Of Medtech Regulations

 
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More from Policy & Regulation

Device Sterilization Plants Get Extra 2 Years To Comply On EtO Phase-Out

 
• By Elizabeth Orr

The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.

Numerous Injuries Prompt Class I Recall Of Dexcom CGM Receivers

 
• By Brian Bossetta

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Experts Call For Database Of Medical Device Labels

 
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