For the second time in four years, the FDA has issued a draft guidance for cybersecurity in premarket applications, just one of several actions undertaken recently by the U.S. federal government in connection with cybersecurity.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocardia, Boston Scientific, Novacyt, Transit Scientific.
The twos have it as the U.S. FDA’s Office of Prescription Drug Promotion, in its second untitled letter of the year, took Bausch Health Cos. Inc. to task over two promotions of its plaque psoriasis lotion, Duobrii (halobetasol propionate and tazarotene).
Making it a done deal, the European Council adopted proposals April 12 to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland and to address supply concerns in Cyprus, Ireland and Malta, which historically have been dependent on drugs from the U.K.
The U.K. plan to fix the market failure in antibiotics has taken a significant step forward with the publication of guidance estimating the value of two drugs to the National Health Service.
Medicine shortages have been of particular concern during the COVID-19 pandemic, and Australia’s Therapeutic Goods Administration said it would seek to amend regulations to allow imports of overseas substitute drugs if the Australian drug has been discontinued and canceled from the Australian Register of Therapeutic Goods.
The China Securities Regulatory Commission has issued draft rules to permit U.S. auditors to examine U.S.-listed Chinese companies on April 2, 2022, following a provisional list by the U.S. SEC. The draft rules specified the requirement for the overseas-listed companies and relevant securities service providers to disclose confidential materials in overseas offerings and listing.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agenus, Aprinoia, Curis, Glenmark, Merck & Co., Priothera, Recursion, Scpharmaceuticals, Spectrum.
Israeli startup Sanolla Ltd. won U.S. FDA 510(k) clearance for its smart-infrasound stethoscope Voqx. The artificial intelligence (AI)-based device is the first stethoscope cleared by the U.S. FDA to detect infrasound and audible information to identify clinical conditions. The auscultation capabilities are designed to support early assessment of cardiopulmonary conditions.
Ossio Inc. has received FDA clearance for Ossiofiber suture anchors used to fix soft tissue to bone in the shoulder, foot and ankle. This is the most recent of clearances for the company’s intelligent bone regeneration technology which began in 2019 as a possible alternative to permanent fixation implants for the foot and ankle alone.
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