As of Aug. 13, more than 90,000 patients hospitalized in the U.S. with COVID-19 already had been given access to convalescent plasma through a national expanded use protocol (EAP) sponsored by the Mayo Clinic. The FDA’s decision Sunday to grant emergency use authorization (EUA) for the potential therapy will further expand access to convalescent plasma for hospitalized patients throughout the country at a time when fully approved COVID-19 treatments are nonexistent and even EUAs are few and far between.
The COVID-19 pandemic has exerted a massive effect on procedure volumes across the globe, but concerns over supply chains have prompted political officials in Washington to encourage domestic production of drugs. That approach is also in play in a number of nations in the Asia-Pacific region, said Sana Siddiqui of Decision Resources Group, who noted that Beijing wants hospitals in China to ensure that 70% of devices used there are domestically manufactured by 2025.
While the U.S. and other countries are looking to step up their own domestic drug and device manufacturing, a bigger takeaway from the COVID-19 pandemic is the need for resilient supply chains that can withstand a global scramble for products suddenly more in demand than the supply can support.
While the U.S. and other countries are looking to step up their own domestic drug and device manufacturing, a bigger takeaway from the COVID-19 pandemic is the need for resilient supply chains that can withstand a global scramble for products suddenly more in demand than the supply can support.
In its first fully virtual markup session, the House Energy and Commerce Committee Wednesday set aside politics to approve a bill that would make the U.S. Strategic National Stockpile (SNS) a better emergency resource – at least for the next few years.
Ethicon U.S. LLC has prevailed in a preliminary action seeking a temporary restraining order against Advanced Inventory Management (AIM) Inc., of Mokena, Ill., which is accused of having imported and sold surgical supplies falsely bearing the Ethicon trademark. Ethicon, a subsidiary of Johnson & Johnson of New Brunswick, N.J., further alleges the sutures were bacterially contaminated and defective.
Just the name, Strategic National Stockpile (SNS), evokes the image of a huge warehouse, or a series of warehouses spread across the U.S., strategically stocked with all the medical supplies, diagnostics and drugs that will be needed nationwide to respond to any health emergency brought on by terrorists, nuclear attacks, pandemics or other public health hazards. The reality is so much more – and so much less.
In a step toward what may become the new normal, at least for now, the Pediatric Oncology Subcommittee of the FDA’s Oncologic Drugs Advisory Committee is meeting virtually Wednesday and Thursday to review pediatric development plans for four cancer drugs.
Fidget spinners are hand-held toys based on a roller bearing and three weighted lobes, which can spin freely, creating centrifugal force when activated manually.
Fidget spinners are hand-held toys based on a roller bearing and three weighted lobes, which can spin freely, creating centrifugal force when activated manually. Generating centrifugal force with a fidget spinner takes neither electricity nor trained staff. And that has suggested to several researchers that such spinners, under the right circumstances, could be used for centrifugation under circumstances where reliably operating a centrifuge, for whatever reason, is a challenge.
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