STAT News
APRIL 23, 2023
At age 93, struggling with the effects of a stroke, heart failure and recurrent cancer, Teri Sheridan was ready to end her life using New Jersey’s law that allows medically assisted suicide — but she was bedbound, too sick to travel. So last Nov. 17, surrounded by three of her children, Sheridan drank a lethal dose of drugs prescribed by a doctor she had never met in person, only online.
Medical Xpress
APRIL 23, 2023
Self-fitting, over-the-counter (OTC) hearing aids produce self-reported and clinical outcomes similar to those of audiologist-fitted hearing aids for adults with mild-to-moderate hearing loss, according to a study published online April 13 in JAMA Otolaryngology-Head & Neck Surgery.
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BioSpace
APRIL 23, 2023
CBER to Launch Operation Warp Speed for Rare Diseases by Year’s End 4/24/2023
Medical Xpress
APRIL 23, 2023
People who live in countries with more stringent alcohol policies drank less than people in countries with less strict policies, according to a large multi-country analysis published in Alcohol: Clinical and Experimental Research. The more stringent policies were associated with reduced drinking overall and showed more significant associations in drinkers aged 18 to 24 and those with 13 or fewer years of education.
BioSpace
APRIL 23, 2023
Ionis and AstraZeneca Seek to Challenge Alnylam with New ATTR Data 4/24/2023
Medical Xpress
APRIL 23, 2023
A discovery about gene variants of an inflammation 'brake' brings scientists a step closer to personalised treatment for patients at risk of kidney disease and kidney failure.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Clinical Trial Podcast
APRIL 23, 2023
In this episode, we’re going to talk about Postmarket Surveillance Studies. In light of the EU Medical Device Regulation (MDR), medical device manufacturers are required to implement a Postmarket Surveillance (PMS) plan, which in turn may require them to conduct Postmarket Surveillance Studies. To learn about Postmarket Surveillance Studies regulatory requirements, process for collecting clinical data for such studies, key elements of PMS plan, and more, I invited Dr.
Cloudbyz
APRIL 23, 2023
The clinical trial landscape is continuously evolving, with technology playing a crucial role in streamlining processes, managing data, and improving efficiency. Three essential systems that have become integral to clinical trial management are Electronic Trial Master Files (eTMF), Electronic Data Capture (EDC), and Clinical Trial Management Systems (CTMS).
BioSpace
APRIL 23, 2023
Supreme Court Maintains Mifepristone Access 4/24/2023
Cloudbyz
APRIL 23, 2023
In recent years, Clinical Trial Management Systems (CTMS) have revolutionized the way clinical trials are conducted, offering numerous advantages to research organizations, pharmaceutical companies, and Clinical Research Organizations (CROs). One of the most significant features of CTMS platforms is the inclusion of electronic trip reports (eTrip Reports) capabilities.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
BioSpace
APRIL 23, 2023
FDA Action Alert: Biogen/Ionis, Seres, Otsuka/Lundbeck and More 4/24/2023
JAMA Internal Medicine
APRIL 23, 2023
This cohort study examines whether skilled nursing facility (SNF) episode volume and Medicare spending on SNF care changed after introduction of the public health emergency waiver during the COVID-19 pandemic among long-term care residents and other Medicare beneficiaries.
BioSpace
APRIL 23, 2023
FDA Delays Verdict for Daiichi Sankyo’s Quizartinib 4/24/2023
JAMA Internal Medicine
APRIL 23, 2023
Ulyte and colleagues describe Medicare costs associated with the COVID-19–related public health emergency policies, specifically that waiving the requirement that use of the skilled nursing facility (SNF) benefit generally requires a 3-day prior hospital stay. They found substantial increases in use of the SNF benefit that were primarily associated with long-stay residents and largely during the early and worst of the pandemic.
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Drug Patent Watch
APRIL 23, 2023
This chart shows the pharmaceutical companies with the most patents in Ukraine. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is… The post Which pharmaceutical companies have the most drug patents in Ukraine? appeared first on DrugPatentWatch - Make Better Decisions.
FDA Law Blog
APRIL 23, 2023
By Mark A. Tobolowsky & David B. Clissold — The Draft Guidance In February 2023, CDER, CBER, and the Oncology Center of Excellence published a draft guidance titled “ Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products ” (the “Draft Guidance”) to provide recommendations to those considering the use of externally controlled clinical trials to provide evidence of safety and effectiveness of a drug product.
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