pharmaphorum
DECEMBER 11, 2022
It can mean everything from patient-facing disease management apps and wearables to background AI dramatically altering drug discovery or radiological imaging. About half of our talents come from the life sciences industry and clinical research, and the other half come from the tech world – so, totally different backgrounds,” Hadjiat said. “We
XTalks
SEPTEMBER 9, 2022
Related: Xtalks Voices: Magnus Medical CEO Dr. Brett Wingeier Talks About Neurostimulation for Depression – Xtalks Life Science Podcast Ep. The SAINT Neuromodulation Trial. The older approaches often took six weeks for depression to respond, while this approach observed remission from depression in just five days,” said Mark S.
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Delveinsight
SEPTEMBER 2, 2021
This designation was based on positive clinical data from the first 21 Impella ECP patients treated as part of an FDA-regulated early feasibility study and will give priority during the Impella ECP’s regulatory review processes comprising of design iterations, clinical study protocols, and pre-market approval (PMA) application.
XTalks
NOVEMBER 7, 2022
Prospective clinical trials are needed to explore whether changing therapy based on ctDNA dynamics prior to radiologic or clinical progression will improve outcomes compared to our current standard,” added Dr. Bahassi. Regulators may ask at some point to provide that documentation, so it’s important to track that across the study.
pharmaphorum
OCTOBER 4, 2022
On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.
XTalks
MAY 13, 2022
Container closure systems are highly regulated by health agencies. USP and EP Organizations for Container Regulation. The FDA’s CDRH (Center for Devices and Radiological Health) branch would own the filing in this case. shaking, changes in pressure, etc.). Requirements for Primary Packaging Components.
XTalks
AUGUST 30, 2022
A consideration is that for early-stage studies, the regulators usually are happier with a staged unilateral followed by a bilateral procedure to evaluate risks first,” explains Dr. Rodrigues. The Neurology and Radiology departments are vital for consultation and imaging, which is needed to establish baselines for a study.
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