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Home » Topics » Regulatory

Regulatory
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US GAO says HHS lacks funding for pandemic response preparedness plan

Feb. 6, 2023
By Mark McCarty
The U.S. Government Accountability Office (GAO) has sounded off again about the ability of other federal government agencies to respond to future crises and pandemics, arguing that the Department of Health and Human Services (HHS) has not forged a comprehensive assessment mechanism to account for the associated medical countermeasure production needs. However, GAO also remarked that HHS does not have a dedicated funding mechanism to finance these activities, a resource that might not become available until after HHS officials draft a budget for the activities associated with such efforts for congressional review.
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US DOJ withdraws 1996 enforcement discretion policy for hospital capital equipment

Feb. 6, 2023
By Mark McCarty
The U.S. Department of Justice (DOJ) reported the withdrawal of three legacy enforcement policies related to health care, including a 1996 policy that allowed hospitals to share the cost of capital equipment such as MRI systems. The announcement would seem to jeopardize the ability of smaller hospitals and other health care clinical sites to share the cost of these and other examples of costly, high-end equipment, but the damage may not stop there, thanks to the elimination of policies regarding medical information sharing that could impede medical research.
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Varian Halcyon

Varian receives FDA 510(k), CE mark for Halcyon and Ethos radiotherapy systems with Hypersight

Feb. 6, 2023
By Annette Boyle
Varian’s Halcyon and Ethos radiotherapy systems received two regulatory nods in short succession, with both U.S. FDA 510(k) clearance and CE marking. In addition, the company reported that the first patient in the world underwent treatment with a Halcyon system with Hypersight last week.
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U.S. Supreme Court

Innovation impact taking center stage in US Supreme Court enablement case

Feb. 6, 2023
By Mari Serebrov
In preparing for their showdown before the U.S. Supreme Court March 27 on what it takes to enable broad genus claims, both Sanofi SA and Amgen Inc. are warning that future innovation will be at stake if the court accepts the other company’s position.
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HIF-PHI-delity? As FDA spins new tune in CKD anemia with GSK nod, others in class may hope to play along

Feb. 6, 2023
By Randy Osborne
With the U.S. FDA go-ahead Feb. 2 for GSK plc’s oral daprodustat for anemia in patients with chronic kidney disease (CKD), the picture brightened for would-be competitors in the hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor space, including high-profile Akebia Therapeutics Inc., which has appealed last spring’s the complete response letter from gatekeepers with regard to vadadustat.
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Regulatory actions for Feb. 6, 2023

Feb. 6, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lumiradx, SPR Therapeutics.
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Regulatory actions for Feb. 6, 2023

Feb. 6, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D, Gracell, Maat, Octapharma, Orexo, Pharmala, Psycheceutical.
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Orthogen granted IDE approval for medical technology for knee osteoarthritis

Feb. 3, 2023
By Bernard Banga
Orthogen AG received an investigational device exemption (IDE) from the U.S. FDA for its Orthogen technology device. This approval allows the company to start a pivotal trial on the device, used for treating patients with mild stage (II) to severe stage (IV) knee osteoarthritis. The trial will compare improvements in pain levels and function using standalone glucocorticoid injection, the current standard of care, against the Orthogen device.
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MDMA’s Leahey says Medicare breakthrough device coverage still a work in progress

Feb. 3, 2023
By Mark McCarty
The Medical Device Manufacturers Association (MDMA) has led the policy charge for smaller medical device manufacturers for decades, but each year brings its own unique set of hazards and opportunities. In an interview with BioWorld, MDMA President and CEO Mark Leahey said that while the Medicare policy for coverage of breakthrough devices has gone through some unanticipated twists and turns, that policy is not yet fixed and thus there is still some prospect that such a policy will not devolve into a stew of leftovers drawn from existing coverage mechanisms.
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Regulatory actions for Feb. 3, 2023

Feb. 3, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Varian.
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