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Home » Topics » Regulatory

Regulatory
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Device makers not entirely out in the cold in overhaul of Stark, AKS regs

Dec. 13, 2019
By Mark McCarty
Device makers have been scrambling for space in value-based care arrangements even though the pace of adoption of those arrangements has been somewhat tepid. While device makers are not explicitly included in a proposed overhaul of the Stark and Anti-Kickback Statute (AKS) regulations, providers may soon be more engaged in these arrangements, thus providing device makers with more opportunities even if they are not included in the rewrite of the related regulatory provisions.
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Dialogue’s ‘human-in-the-loop’ safety software wins CE marking

Dec. 13, 2019
By David Godkin
TORONTO – Montreal’s Dialogue Technologies Inc. has received class 1 CE marking for artificial intelligence (AI)-powered software that enables the company’s existing telehealth platform to reduce the time required to triage patients in emergencies. The new AI-driven Dialogue Intake software also has “human-in-the-loop” capability ensuring real-time medical intervention to verify the accuracy of information provided physicians during telehealth consultation.
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Newborn feet

FDA gives nod to first newborn screening test for Duchenne muscular dystrophy

Dec. 13, 2019
By Meg Bryant
Perkinelmer Inc., of Waltham, Mass., has won a thumbs up from the U.S. FDA for its GSP Neonatal Creatine Kinase-MM kit. The assay is the first test approved in the U.S. for help in screening newborns for Duchenne muscular dystrophy (DMD), a rare but devastating genetic disorder. While there is no known cure for DMD, earlier screening and diagnosis could lead to improvements in quality of life by enabling earlier and more personalized treatment of symptoms. The kit’s approval opens the door for states to include DMD among the battery of tests newborns typically undergo, such as phenylketonuria, cystic fibrosis and congenital heart disease.
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FDA’s change of heart

Sarepta’s Vyondys 53 wins a surprise accelerated approval

Dec. 13, 2019
By Lee Landenberger
In August the FDA was skeptical about Sarepta Therapeutics Inc.’s injectable Vyondys 53 (golodirsen), but that changed swiftly Friday with the agency’s accelerated approval for the Duchenne muscular dystrophy (DMD) follow-on therapy, the first treatment specifically for this subtype.
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Thumbs up

The eyes have it: Adcom slam-dunk vote favors Horizon thyroid candidate

Dec. 13, 2019
As expected, Horizon Pharma plc sailed through the meeting of the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee regarding the BLA for teprotumumab in thyroid eye disease (TED) with few surprises but much discussion.
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Two positive CHMP opinions in December take 2019 tally to 41

Dec. 13, 2019
By Cormac Sheridan
DUBLIN – The European Medicines Agency’s Committee for Medicinal Products for Human Use closed out its year’s work with positive opinions on two applications, Novartis AG’s Beovu (brolucizumab) in wet age-related macular degeneration and Merck & Co. Inc.’s Recarbrio for treating gram negative infections in adults.
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Regulatory front for Dec. 13, 2019

Dec. 13, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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EMA takes pharmacovigilance to the next level: ‘Nearly’ real-time decision-making

Dec. 13, 2019
By Nuala Moran
LONDON – Over the next decade pharmacovigilance will move on from a sole focus on adverse drug reactions (ADRs) to encompass monitoring of the in-market efficacy of medicines, according to Guido Rasi, executive director of EMA.
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FDA’s change of heart: Sarepta’s Vyondys 53 wins surprise accelerated approval

Dec. 13, 2019
By Lee Landenberger

FDA grants accelerated approval to Vyondys 53 for DMD in patients amenable to skipping exon 53

Dec. 13, 2019
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