While the FDA’s approach to evaluating safety and efficacy in the development and review of COVID-19 vaccines for the U.S. market will be at the center of its Oct. 22 advisory committee meeting, the panel also will be asked to discuss the practicalities, and ethics, of continuing to conduct trials once a candidate has been granted an emergency use authorization.
Keeping you up to date on recent developments in orthopedics, including: Magnetic field and hydrogels could be used to grow new cartilage; COVID-19 pandemic has dramatic impact on osteoporosis management, finds new global study; Casting call: Why immobilizing helps in healing; Osteoarthritis biomarker could help 300 million people worldwide.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed says shipped tests reach 200M mark; Brazil, U.S. expand on 2011 trade handshake; Federal Circuit reaches split decision in review of IPR.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acuitive, Appliedvr, Certest, Tyber, Venturemed.
The U.S. FDA’s device center has declared it will not review emergency use authorization (EUA) requests for lab-developed tests (LDTs) for the COVID-19 pandemic, but on the agency’s most recent town hall, on Oct. 14, FDA officials were uncertain as to whether labs should file those EUAs, leaving labs in a state of limbo yet again.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clinical Enterprise, Ezra, Spectrum Solutions.
COVID-19 continues to dominate biopharma nonprofit collaborations and grants in 2020, with the pandemic accounting for 85% of projected values reported this year, most of which have posted since the start of July.
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