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FDA’s new head of device safety held senior role at company troubled by safety warnings
“Olympus’ continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety,” said Jeffrey ...
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FDA names new head of medical device evaluation and quality
Recommended Reading FDA defends Shuren’s tenure after report raises ethics concerns The Food and Drug Administration named Ross Segan as director of the medical device center’s Office of ...
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Pfizer starts voluntary withdraw of OXBRYTA, benefit does not outweigh risks
Pfizer withdraws OXBRYTA after post marketing studies showed that the risks of side effects were greater than the benefits.
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‘Closer to US commercialisation’ – EBR achieves major FDA milestone
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SENA Panel: Everyone’s Targeting Seafood – CBP Forced Labor, Proposition 65, PFAS, and FDA
An on-demand video of “Everyone’s Targeting Seafood – CBP Forced Labor, Proposition 65, PFAS, and FDA” is available free for ...
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STAT+: FDA's new head of device safety held senior role at company troubled by safety warnings
“Olympus’ continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety,” said Jeffrey Shuren, head of FDA’s medical devices center, at the time.
medtechdive5d
FDA names new head of medical device evaluation and quality
Ross Segan was chosen to lead the office, which handles premarket authorizations and recalls, in the agency’s Center for Devices and Radiological Health.
Pfizer starts voluntary withdrawal of OXBRYTA, benefit does not outweigh risks
The withdrawal comes after postmarketing studies showed that the risks of side effects were greater than the benefits.