With the public health emergency for the COVID-19 pandemic rapidly winding down, the U.S. FDA has published guidance for the transition of COVID-specific diagnostic tests and other articles to conventional premarket review mechanisms.
The U.S. FDA has released a final guidance for the agency’s refuse-to-accept (RTA) policy for cybersecurity measures in medical devices, a policy document that was required by Congress via the Consolidated Appropriations Act for the 2023 federal fiscal budget.
Comanche Biopharma Corp. has received IND clearance from the FDA to conduct a first-in-human study of CBP-4888, its novel, small interfering ribonucleic acid (siRNA) therapy to treat pre-eclampsia.
U.S. FDA commissioner Robert Califf went to Capitol Hill ostensibly to answer questions about the agency’s budget request for fiscal 2024, but the conversation quickly focused on issues such as baby formula and food supply security.
The U.S. FDA granted Graymatters Health Ltd. 510(k) clearance to market Prism for PTSD, a non-invasive, self-neuromodulation adjunct digital therapy for post-traumatic stress disorder (PTSD).
U.S. lawmakers have been busy writing to government agencies demanding answers and explanations on a range of issues, including drug shortages, gain-of-function research and thickets of duplicative patents that extend patent protection well beyond 20 years for some prescription drugs.
The U.S. FDA gave Bot Image Inc. a coveted threefer with 510(k) clearance for its Prostatid artificial intelligence (AI) software for detection, diagnosis and monitoring of prostate cancer using both standard MRI and a non-invasive bi-parametric MRI, which does not require a contrast agent.
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