While the ultimate goal is increased diversity in clinical trials so as to improve health equity, a great start is making diversity a priority and a part of the research plan, Luther Clark, deputy chief patient officer at Merck & Co. Inc., said during an FDA Office of Minority Health and Health Equity webinar Sept. 22.
The latest global regulatory news, changes and updates affecting biopharma, including: New TGA service to ease the burden of biowaivers; FDA formalizes outside experts program; FDA unveils Digital Health Center of Excellence; FDA updates clinical trial guidance.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ADC, BMS, Crispr, Emmetrope, Genocea, Knight, Lilly, Medeor, Mustang, Nicox, Ocumension, Redhill, Therapeuticsmd, UCB, Vertex.
TORONTO – Ka Imaging Inc. has received U.S. FDA 510(k) clearance for a portable, dual-energy X-ray detector that distinguishes itself from others in this class by delivering regular digital radiography, bone and tissue images in a single X-ray exposure. Designed for early detection of pneumonia, including COVID-19, the Reveal detection system also differentiates bone and soft-tissue.
The field of artificial intelligence (AI) is stretching the boundaries of conventional med-tech regulation, and several regulatory agencies are working to cut that Gordian knot. Marc Lamoureaux, director of digital health at Health Canada’s (HC) medical device directorate, said on a Sept. 21 webinar that legislation passed in 2019 gives the agency a “regulatory sandbox” in which to experiment with AI regulation, a mechanism he said may bring these algorithms to market much more rapidly than would otherwise be the case.
Visby Medical Inc. emerged from stealth mode to secure emergency use authorization (EUA) from the U.S. FDA for its Personal PCR device for detection of COVID-19 infections. It is the first FDA-authorized portable device to use the polymerase chain reaction technology for COVID-19 testing. The San Jose, Calif.-based company was known as Click Diagnostics Inc. until March 2020.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Axonics, Simplify Medical, Visby Medical.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alexion, Ampio, Arca, Astrazeneca, Crinetics, I-Mab, Merck, Otsuka, Harbour and Liminal.
The latest global regulatory news, changes and updates affecting biopharma, including: CDER lays out public speech rules for staff; Health Canada opens quicker path for COVID-19 drugs; EMA OKs COVID-19 use of dexamethasone.
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