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From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

FDA Law Blog

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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

FDA Law Blog

FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices. However, in our experience, there is a large gap between FDA’s lauding the value of RWE and practice. percent of examples.

Medical 111
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Episode 148: Antiracism in Medicine Series Episode 4 – Dismantling Race-Based Medicine Part 2: Clinical Perspectives

The Clinical Problem Solvers

Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice. Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality.

Clinic 52
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You don’t need X-Rays in a child with bronchiolitis, croup, asthma, or first time wheezing

PEMBlog

ED providers and radiologists commonly face the scenario of interpreting a CXR in a child with respiratory complaints prompting the questions: Does that infiltrate represent bacterial pneumonia, inflammation, or simply atelectasis? Drivers of CXR overuse are myriad and can be thought of at the system, provider, and patient levels.

Asthma 52
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Screening for Dementia: A Podcast with Anna Chodos, Joseph Gaugler and Soo Borson

GeriPal

Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. There has to be effective support provided behind any type of screening strategy in order for it to truly be effective.

Screening 119
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Are your patients satisfied?

Physician's Practice

Welcome to Five Minute Practice Fix, featuring instructional videos by physician and business of medicine expert Neil Baum, M.D. Dr. Baum is Professor of Clinical Urology at Tulane Medical School in New Orleans, Louisiana. He has also written The Complete Business Guide to a Successful Medical Practice, which was published in 2015.

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Hearing Loss in Geriatrics and Palliative Care: A Podcast with Nick Reed and Meg Wallhagen

GeriPal

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. Association of Sensory and Cognitive Impairment With Healthcare Utilization and Cost in Older Adults.

IT 102