The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ONC delays health IT compliance dates due to COVID-19; DOJ drops $8.1 million fine on Medtronic over FCA violation; CMS posts DME draft rule; NIH lays out final policy on data sharing; NICE posts two health technology assessments.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chf Solutions, Dia Imaging Analysis, Illuminoss Medical, Medtronic.
The latest global regulatory news, changes and updates affecting biopharma, including: NIH lays out final policy on data sharing; NICE to review Spinraza data; Olinvyk a Schedule II; FDA issues REMS MAPP.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apstem, Asieris, Avrobio, Genprex, Insignis, Mesoblast, Oncosec, Pepromene, Rafael, Regeneron, Tricida.
Developers of tests for the COVID-19 pandemic are deploying an increasingly wider range of test systems for molecular testing, but the FDA’s Toby Lowe said that despite the seeming interchangeability of real-time PCR (rt-PCR) systems, performance of a reference panel for a tweaked test must reflect the use of the rt-PCR system that is listed in the existing emergency use authorization (EUA).
Neuroem Therapeutics Inc. has received breakthrough device designation from the U.S. FDA for Memorem, a bioengineered, wearable head device for the treatment of Alzheimer’s disease. The breakthrough nod, which entitles companies to an expedited regulatory process, follows results from a pilot study showing Memorem can reverse memory loss in patients with the debilitating brain disorder.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advisory hearing gives Neovasc Reducer poor marks for efficacy; CMS eyes expanded DME coverage of CGMs; APEC launches Vision 2025 for business ethics; Innovation Alliance voices support for Iancu, PTAB changes.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas Pharma, Cognita Labs, Medical Microinstruments, Neuroem.
The latest global regulatory news, changes and updates affecting biopharma, including: Lawmakers spill Purdue documents on heels of settlement; Western states join forces to review vaccines; FDA finalizes nicotine drug guidance; CBER tackling guidance agenda; Innovation Alliance voices support for PTAB changes.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aprinoia, Astellas, Astrazeneca, Daiichi Sankyo, Insmed, Passage, Qualigen, Revision, Taysha Gene Therapies.
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