Brief summaries of recent advances in device research and clinical trials, including a promising new retinal implant and new findings in the field of radiation therapy.
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Federal law requiring agencies to weigh and document potential environmental impacts of major regulatory actions does not dictate what happens next. Neither does it provide federal agencies with authorities beyond their statutory purviews, FDA/CDER leadership says.
The European Medicines Agency has reported progress with a collaborative project that involves other regulators in its assessments of COVID-19 products, and with the EU Medicines for All initiative for evaluating products for non-EU markets.
A potential decline in mRNA vaccine protection against the Delta variant is raising questions about the need for booster shots in the US. Ocugen Inc. and partner Bharat Biotech hope the changing dynamic of COVID-19 in the US will induce the FDA to reconsider additional clinical trial requirements for Covaxin, an inactivated whole virus vaccine authorized for emergency use in 16 countries.