The FDA has taken a hands-off approach to general wellness products that take up residence in smartphones, but that doesn’t mean these products aren’t subject to regulatory drift.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neuropace, Sight Sciences.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Enlivex, Evofem, Iveena, Kalvista, Kyowa, Mei, Moderna, Modus, Pfizer, Promore, Sofie.
Kaléo Inc. agreed to pay $12.7 million to end whistleblower allegations that the Richmond, Va.-based company caused the submission of false claims for Evzio (naloxone hydrochloride), an injectable drug used to reverse opioid overdoses.
India is home to just one of several regulatory entities that have overhauled their med-tech regulatory apparatus in recent years, but the Central Drugs Standard Control Organization (CDSCO) has also joined the COVID-19 regulatory delay club as well.
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).
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