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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.” By Jeffrey N.

Medical 111
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Human papillomavirus vaccination in community-based clinics among adolescents by ethnicity, country of birth, and sex [Screening, prevention, and health promotion]

Annals of Family Medicine

Conclusions This study shows wide variation among HPV vaccine uptake among children and adolescents in a multi-state network of community-based clinics, with higher uptake in Latino patients, especially foreign-born Latinos.

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FDA’s Accelerated Approval of Biogen’s Aduhelm for Alzheimer’s: A Sign of Applying the Emergency Use Standard Beyond COVID?

FDA Law Blog

However, the FDA guidance goes on to say in some cases, additional context is needed by specifically inserting a sentence in the indications statement that: no clinical benefit has been established. be “reasonably likely to predict” ultimate clinical benefit). Janet Woodcock approved Betaseron as the first drug for multiple sclerosis.

Clinic 98
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Under Pressure: Hypertensive Emergencies in the Pediatric Emergency Department

PEMBlog

Clinical Case You are a senior resident working in the busy emergency department on an overnight shift. Hypertensive emergency is a clinical diagnosis characterized by a sudden and severe elevation in blood pressure accompanied by signs of acute end-organ dysfunction. Look for the underlying cause renal disease leads the list in kids.

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End-of-Life Doulas: A Podcast with Jane Euler, Beth Klint, and John Loughnane

GeriPal

An end-of-life doula is a non-medical support person that provides a longitudinal relationship with aspects of medical, I mean, aspects of companionship, presence, holding space, some logistics, some practical help, decision making perhaps. There’s an organization that I took my training from, which began, I want to say, in 2012.

Provider 117
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RCT of Default Inpatient PC Consults: Kate Courtright & Scott Halpern

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. Eric: Yeah.

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The impact of gun violence and practical tips on firearm safety: A podcast

PEMBlog

Pediatrics November 2012; 130 (5): e1416–e1423. 2012-2481 Haasz, M., I’m Dr. Carney and I am a pediatric resident at Cincinnati Children’s Hospital Medical Center. Today, we are going to discuss firearm safety and ways to screen for it in both the ED and clinic settings. Melzer-Lange, Joseph O’Neil, Wendy J. Beidas, R.

Family 52