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Clinical Trial Challenges: FDA, NIH Chiefs Chat, Amid Uncertain Future

 
• By Brenda Sandburg

NIH Director Collins and FDA Commissioner Califf discuss difficulties with ‘big science,’ ‘small crappy trials,’ and ‘data landlords.’

NIH Director Francis Collins and FDA Commissioner Robert Califf.

National Institutes of Health Director Francis Collins and FDA Commissioner Robert Califf got to joke around a little on stage at the Faster Cures Partnering for Cures meeting in New York Nov. 15. The exchanges were thoughtful and entertaining, but more than anything they served to underscore the uncertainty over the future direction of federal health policy after the surprise election of Donald Trump as president.

Califf appeared on a panel that Collins moderated about the challenges in pursing “big science” initiatives like the Precision Medicine...

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• By Marion Webb

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NIH-Backed Scanner Opens New Frontier For Understanding The Human Brain

 
• By Brian Bossetta

A new MRI scanner developed by a team of scientists working with the National Institutes of Health marks a milestone in understanding the complexities of the human brain. Andrea Beckel-Mitchener with the NIH Brain Initiative discusses the significance of this potentially game-changing device.

Boston Scientific Raises Outlook … Again: Headwinds Offset By EP And Watchman

 
• By Natasha Barrow

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Abbott Lowers Outlook But Headwinds Are Temporary

 
• By Natasha Barrow

Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.

More from R&D

Boston Scientific Raises Outlook … Again: Headwinds Offset By EP And Watchman

 
• By Natasha Barrow

Agent drug coated balloon, Watchman product sales, and electrophysiology (EP) business unit growth offset Acurate discontinuation and tariff headwinds. CEO Michael Mahoney shouted out coronary therapies business and answered questions on CMS proposed Ambulatory Surgical Center codes.

FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

 
• By Elizabeth Orr

The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.

Opinion: Catch A Fraudulent Scientist -- If You Can

 
• By Ivor Campbell

As AI tools make research fraud and résumé fraud easier than ever, life sciences companies need to take steps to protect themselves. Snedden Campbell CEO Ivor Campbell has some tips on successful strategies.