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BioWorld - Wednesday, December 31, 2025
Home » Topics » Regulatory

Regulatory
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Stephen Hahn, nominee for FDA commissioner

Hahn just a Senate vote away from becoming the FDA’s next commissioner

Dec. 3, 2019
By Mari Serebrov
With today’s 18-5 vote in the Senate Health, Education, Labor and Pensions (HELP) Committee to send Stephen Hahn’s nomination to the full U.S. Senate, the oncologist who currently serves as chief medical officer at the MD Anderson Cancer Center is just a step away from being confirmed as the next FDA commissioner.
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Ear illustration

FDA gives thumbs up to Cochlear’s implantable bone conduction hearing system

Dec. 3, 2019
By Tamra Sami
The U.S. FDA has cleared Cochlear Ltd.’s newest cochlear implant, the Osia 2 system, an active implantable bone conduction hearing system. Unlike Cochlear’s traditional implant, the Osia implant bypasses damaged parts of the ear and sends sound vibrations directly to the cochlea.
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Regulatory front for Dec. 3, 2019

Dec. 3, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory front for Dec. 3, 2019

Dec. 3, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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U.S. flag, stethoscope

Stakeholders press CMS to allow repeat testing in do-over of NGS coverage memo

Dec. 2, 2019
By Mark McCarty
The Medicare coverage memo for next-generation DNA sequencing (NGS) was reopened to allow for NGS testing for other than late-stage cancers, but stakeholders are urging the U.S. Centers for Medicare and Medicaid Services (CMS) to allow repeat testing, another change that would considerably boost utilization.
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China updates reimbursement drug list, further encourages innovation at home

Dec. 2, 2019
By Elise Mak
BEIJING – China has updated its national reimbursement drug list (NRDL) to include innovative drugs that it has recently approved, including homegrown cancer drugs and foreign imports. Industry experts said they believe it is a move to drive biotech innovation at home.
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Regulatory front for Dec. 2, 2019

Dec. 2, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front for Dec. 2, 2019

Dec. 2, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
Read More

Chidamide approved in China for breast cancer indication

Dec. 2, 2019

NMPA approves flumatinib mesylate for the treatment of Ph+ chronic myeloid leukemia

Nov. 29, 2019
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