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BioWorld - Monday, December 16, 2019
Home » Topics » Regulatory

Regulatory
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Device accessories are eligible for FDA safer technologies program

November 19, 2019
By Mark McCarty
No Comments
The FDA’s Safer Technologies Program, or STeP, is part of an overarching emphasis on safety, and the related draft guidance focuses largely on the process of applying for a STeP device. However, a member of the FDA staff said on a webinar that device accessories – and devices that make other devices safer – are also eligible for the program.
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Beigene wins its first FDA nod with BTK inhibitor Brukinsa

November 19, 2019
By Elise Mak
No Comments
BEIJING – Beijing-based Chinese biotech giant Beigene Ltd. said Brukinsa (zanubrutinib) won accelerated FDA approval to treat adults with mantle cell lymphoma (MCL) who received at least one prior therapy. This is the first China-discovered innovative cancer drug to win FDA clearance. Beigene said Brukinsa is the only FDA-approved BTK inhibitor shown to deliver 100% median occupancy in peripheral blood cells. It is also the only BTK inhibitor that can be taken once or twice daily. Brukinsa is expected to be launched in the U.S. in the coming weeks.
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FDA approval of Shionogi antibacterial sets stage for move into new market

November 19, 2019
By Michael Fitzhugh
No Comments
Adults with complicated urinary tract infections (cUTIs) and limited or no alternative treatment options could soon receive Shionogi & Co. Ltd.'s cefiderocol following FDA approval for the antibacterial. The approved indication also included kidney infections caused by susceptible gram-negative microorganisms. The new therapy, to be marketed as Fetroja, is expected to be available in early 2020.
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EMA advancing strategy for future regulatory science, with new tech, real-world data

November 19, 2019
By Nuala Moran
No Comments
LONDON – “Innovation only matters if patients benefit.” So said Guido Rasi, executive director of the EMA, as the agency embarks on the next phase of updating its regulatory science, both to tap into a torrent of new technologies and to ensure drug development generates evidence to demonstrate cost effectiveness and speed up access.
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Regulatory front for Nov. 19, 2019

November 18, 2019
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The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Coopervision wins FDA nod for first contact lens to slow advance of myopia in children

November 18, 2019
By Meg Bryant
No Comments
The U.S. FDA has given its final approval to Coopervision Inc.'s Misight 1 day, the first contact lens designed to slow the progression of myopia, or near-sightedness, in children. The single use, disposable, soft contact lens is indicated for children who are diagnosed with myopia and begin Misight treatment at an early age. Specifically, the FDA indication said that "Misight (omafilcon A) daily wear single use soft contact lenses are indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤ 0.75 diopters of astigmatism. The lens is to be discarded after each removal."
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Regulatory front for Nov. 18, 2019

November 18, 2019
No Comments
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Final guidance retains restrictions to devices exported from U.S.

November 18, 2019
By Mark McCarty
No Comments
The U.S. FDA draft guidance for appeals for denial of certificates for export indicated that the scope was limited to devices exported from physical locations in the U.S. This provision appears in the final guidance as well – despite arguments that it flies against the text of the Food and Drug Administration Reauthorization Act of 2017 (FDARA)
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Deep Bio wins CE marking of AI-based prostate diagnosis software

November 18, 2019
By Jihyun Kim
No Comments
HONG KONG – South Korean biotech Deep Bio Inc. has won CE marking for its artificial intelligence (AI)-powered medical software DeepDx-Prostate Connect.
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Regulatory front for Nov. 18, 2019

November 18, 2019
No Comments
The latest global regulatory news, changes and updates affecting biopharma.
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