Entities that lack experience in FDA regulation of medical devices may find the going both expensive and time consuming, but there are resources available to these players in the digital health space. Bakul Patel, director of the Digital Health Center of Excellence at the FDA’s device center, said that while he understands that reading through agency guidance is an unpleasant task, the companies that take the time to do so may find their interactions with the agency less iterative and more productive, thus speeding their path to market.
China's National Health Commission (NHC) has released a draft regulation to set entry requirements for the internet health care industry. The draft poses some strict requirements, such as a ban on online consultations for the initial diagnosis. It also prohibits the practice of linking doctors’ income to the sales of drugs and medical devices.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Heartvista, Vektor Medical, Siemens Healthineers.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bergenbio, Dragonfly, Glaxosmithkline, Inovio, Moderna, Pharmaxis, Plus.
Lawfully selling prescription opioid drugs is not a public nuisance, the Oklahoma Supreme Court said in overturning a $465 million judgment against Johnson & Johnson (J&J).
As part of its pharmacovigilance program for Alzheimer’s drug Aduhelm (aducanumab), Biogen Inc. is evaluating a handful of reports published in the FDA Adverse Event Reporting System Public Dashboard, including the Aug. 18 death of a 75-year-old woman with Alzheimer’s and other co-morbidities.
Arthrex Inc., of Naples, Fla., is well known for lobbing a legal hand grenade into the inter partes review (IPR) process for patent disputes, but the company is now drawing ink for a different legal reason. According to the U.S. Department of Justice (DoJ), Arthrex has agreed to pay $16 million to settle allegations that it engaged in kickbacks to a surgeon, payments ostensibly made to pay for assistance with device design, but which the DoJ claims were intended to induce the surgeon’s use and endorsement of Arthrex products.
The U.S. Centers for Medicare & Medicaid Services (CMS) has withdrawn the proposal to provide automatic Medicare coverage of FDA breakthrough devices, but the proposal may not be as dead as it once seemed.
PARIS – The French National Agency for the Safety of Medicinal and Healthcare Products (ANSM), has published its latest annual report on the drugs and medical devices market in France. This body, placed under the supervision of the Ministry of Health, is responsible for monitoring all healthcare products throughout their cycle, for collating and analyzing reports of adverse reactions, and for implementing corrective action across the nation.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: CMR Surgical.
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