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FDA Safety Communications: A Potential Provider Pitfall

The FDA Law Blog

Valley Hospital, Inc. 25, 2022), [link] , considered whether a provider’s use of a medical device that is the subject of an FDA safety communication constitutes per se evidence of wanton disregard, which would warrant punitive damages. Thus, the Safety Communication could play a role in further proceedings in the case.

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Digital tool cuts hospital readmissions in cirrhosis patients

pharmaphorum

A digital patient monitoring tool developed by UK company CyberLiver has been given a breakthrough designation by the FDA for out-of-hospital management of patients with cirrhosis at risk of complications. The post Digital tool cuts hospital readmissions in cirrhosis patients appeared first on.

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Comparison Of Rebyota Versus Vowst: A Study Table To Help You Compare Fecal Microbiota Therapies

IDStewardship

These advancements are evidenced by the two FDA-approved FMT products available for rCDI prevention: Rebyota (Fecal Microbiota, Live-jslm) and Vowst (Fecal Microbiota Spores, Live-brpk). Rebyota, a solution delivered via enema, was the first FMT product to be FDA-approved. Am J Gastroenterol. Jain N, Umar TP, Fahner AF, Gibietis V.

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Can you take Breztri Aerosphere for asthma?

The Checkup by Singlecare

It is approved by the Food & Drug Administration (FDA) for long-term treatment of adults with chronic obstructive pulmonary disease (COPD). Breztri is approved by the FDA for the maintenance treatment of COPD in adults. You may need to go to the hospital for treatment. This effect does not apply to people with COPD.

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Can a nasal spray tackle agitation in autism?

Pharmaceutical Technology

Dr Jeremy Veenstra-VanderWeele, professor of developmental neuropsychiatry at the Columbia University Irving Medical Center, explains that agitation is seen in the minority of autistic teens, who struggle with communication. An inability to clearly communicate with others and express their wants and needs results in frustration, he adds.

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NASP 2022 Reveals a Pharmacy Landscape Shifting to Specialty

Omnicell

Namely, there are currently more than 400 new cell and gene therapies under development, and 60 percent of the new molecular entities awaiting FDA approval are specialty pharmaceuticals. However, there are several barriers that can make this move difficult for many hospitals.

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Advancing Healthcare Accessibility: Point-of-Care Testing in Independent Pharmacies

Digital Pharmacist

Independent pharmacies have emerged as pivotal players in this arena, offering point-of-care testing (POCT) services that not only enhance healthcare accessibility but also alleviate the strain on hospitals and healthcare systems. While it offers moderate sensitivity, recent FDA regulations mandate higher sensitivity thresholds.