In a span of a mere two years, the state of California passed two ballot initiatives dealing with privacy that promise to have an impact on digital health, the second of which created an office specifically for privacy enforcement matters. Eric Goldman, a professor of law at the Santa Clara (California) University School of Law, said on a recent webinar that the state attorney general’s office and the new California Privacy Protection Agency (CPPA) have overlapping jurisdiction, and as a consequence, companies doing business in California may find themselves at the mercy of not one, but two enforcement entities.
The latest global regulatory news, changes and updates affecting biopharma in Asia, including: Biontech, EMA, Health Canada, Minister of Health, Moderna, NIH, Pfizer, PhRMA, WHO.
Mouse traps. Bird excrement. Insects. Rusted equipment and peeling paint. Employees not gowning properly for a clean room or washing their hands after using the bathroom. Those are just some of the things the FDA is missing as it relies on document reviews, sampling at the border and other alternatives to onsite drug inspections during the pandemic.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Rep. Payne resurrects colorectal cancer screening bill; Former Practice Fusion employee enters guilty plea; NICE says Alpha-Stim not ready for anxiety disorder.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Able Medical, Eitan Medical, Empatica, Inivata, Mahana Therapeutics, Roche.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Affibody, Alphamab, Altrubio, Amylyx, Cyclo, Huya, Inmagene, Melior, Oncopeptides, Rocket.
Cue Health Inc. became the first company to offer COVID-19 molecular testing for home use without a prescription following U.S. FDA emergency use authorization on March 5, 2021. The San Diego-based company’s isothermal nucleic acid amplification test (NAAT) detects RNA from SARS-CoV-2 virus present in the nostrils. “The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “Cue COVID-19 Test for Home and Over-the-Counter (OTC) Use provides access to accurate and reliable testing at-home, without a prescription.”
Medical device startup Promaxo Inc. has received 510(k) clearance from the U.S. FDA for its office-based MRI system. The portable system is intended for use by urologists and interventional/urologic radiologists who are performing surgical localization of prostatic lesions under Promaxo MRI guidance. It can be used in the office or outpatient surgical setting without the need for significant facility upgrades.
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