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FDA Cracks Down on ClinicalTrials.gov Reporting Failures

FDA Law Blog

On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The ClinicalTrials.gov database is a public database of clinical studies administered by the U.S. The notice was given to Acceleron Pharma, Inc., National Library of Medicine. 42 U.S.C. §

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FDA Cracks Down on ClinicalTrials.gov Reporting Failures

FDA Law Blog

Butler — On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The ClinicalTrials.gov database is a public database of clinical studies administered by the U.S. The notice was given to Acceleron Pharma, Inc., National Library of Medicine.

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Episode 275: Anti-Racism in Medicine Series – Episode 19 – Reframing the Opioid Epidemic: Anti-Racist Praxis, Racial Health Inequities, and Harm Reduction

The Clinical Problem Solvers

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. A more Western perspective on health care emphasizes the role of physicians and health care providers and marginalizes the role and contributions of doulas and midwives.

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EMS Intervention to Reduce Falls: Carmen Quatman and Katie Quatman-Yates

GeriPal

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. And yet, after assisting the older adult to their feet, the EMS providers would leave. I think, as providers, we don’t get to see that.

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Bisphosphonates for Osteoporosis: Podcast with James Deardorff and Sei Lee

GeriPal

This tool provides a clinical recommendation for starting/stopping medications and cancer screening based on the prognosis of the patient in front of you. And they really have been shown in several clinical trials to have reductions in vertebral fractures, non-vertebral fractures, and hip fractures. See screenshot below.

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RCT of PC in ED: Corita Grudzen, Fernanda Bellolio, & Tammie Quest

GeriPal

Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. Alex 00:31 And we’re delighted to welcome Fernanda Bellolio, who is an emergency medicine physician and professor of emergency medicine at the Mayo Clinic. Corita 00:30 Thank you.

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GeriPal 300th Episode: Ask Me Anything Hot Ones Style

GeriPal

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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