PERTH, Australia – The Australian government is recommending that Australians under 50 take the Pfizer Inc. COVID-19 vaccine due to the risk of rare blood clots associated with Astrazeneca plc’s COVID-19 vaccine (ChAdOx1-S). The move jeopardizes Australia’s vaccine rollout as it had planned for the majority of Australians to receive the Astrazeneca vaccine, which is being locally manufactured by CSL Ltd.
The COVID-19 pandemic’s direct and indirect toll on the human condition is beyond calculation, but the effect on FDA regulatory activity is easier to assess. The problem for device makers is that a number of draft and final guidances are stuck in a pandemic-driven regulatory limbo, which seemingly guarantees that some compliance and product development efforts will run afoul of the agency’s expectations and potentially delay a product’s market access.
Speaking during the 2021 China Pharmaceutical Innovation 100 Summit, industry insiders called for more regulatory talent and even an organizational revamp to clear innovative products faster and support the global development strategies of Chinese drugmakers.
SHANGHAI – China’s regulatory environment has evolved to encourage drug innovation, but despite remarkable progress, mounting pricing pressure from the government and a weak insurance sector remain as barriers.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NICE needs more evidence for Clarity RMS for AKI; Thermacor disposable sets recalled.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acutus Medical, Hemanext, Lumiradx.
The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee will be venturing into new territory April 15 in which it not only has to consider whether the benefit of Celltrans Inc.’s donislecel is clinically meaningful, but it also will have to define the indication.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akouos, Avenue, Axcella Health, Celularity, Janssen, Kibow, Lintonpharm, Neuraptive, Novartis, RDIF, Vtv.
The FDA and the CDC have jointly recommended a temporary pause in the further rollout of Johnson & Johnson Co.’s COVID-19 vaccine while they investigate six rare clotting cases in adults ages 18 to 48.