Sat.Sep 30, 2023 - Fri.Oct 06, 2023

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Episode 304: Spaced Learning Series – The Journey of 3Hs: Hyperbilirubinemia, Hypoxia and Hemolysis

The Clinical Problem Solvers

[link] Episode description: The spaced learning series team discusses a case of a patient with hyperbilirubinemia secondary to acute alcoholic hepatitis, who then developed hypoxia and hemolysis. Featuring: Anna Fretz Priyanka Athavale Kirtan Patolia Schemas Hyperbilirubinemia Hypoxemia Hemolysis Download CPSolvers App here RLRCPSOLVERS Click here to view the weekly episode recap email!

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Proposed LDT Rule Raises Many Questions but Provides Few Answers

FDA Law Blog

By Allyson B. Mullen & Gail H. Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). There is much to unpack, and we intend to do so in a series of blog posts. In this post, we focus on the proposed changes themselves, and the many questions the agency leaves unanswered.

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Atherosclerosis: Understanding the Pathophysiology - Clinical Correlations

Clinical Correlations

By Zachary Henig Peer Reviewed Atherosclerosis is the primary risk factor for cardiovascular disease, the leading cause of mortality worldwide. To understand the pathophysiology of atherosclerosis, we turn to advances made in molecular biology. Understanding the.

Clinic 52
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The Language of Serious Illness: A Podcast with Sunita Puri, Bob Arnold, and Jacqueline Kruser

GeriPal

Summary Transcript Summary Communicating about a serious illness is hard. Last week’s podcast we talked about the challenge around miscommunication in serious illness. This week we dive into the challenges with communication when it comes to life sustaining treatments and CPR. Take for example the simple question: “If her breathing gets any worse, she will need to be intubated.

Illness 136
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Breast Cancer Awareness

Family Physicians of Greeley

One of the scariest things to ever hear is that you or a loved one has been diagnosed with cancer. Would you be surprised to learn that 1 in 8 women are diagnosed with breast cancer in their lifetime? Breast cancer is the most commonly diagnosed cancer In the United States. Every 2 minutes a woman is diagnosed with breast cancer. That’s right, by the time you are finished reading this, there will be 2 more women who will find out they have breast cancer.

PCP 40
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Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List)

FDA Law Blog

By Charles G. Raver & James E. Valentine & Frank J. Sasinowski — This time last year, we wrote about a long-overlooked FDA statutory authority and wondered if this provision, known colloquially as the “single study plus confirmatory evidence” pathway, was having a moment (previous post here ). Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy.

IT 64
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Another DOJ Self-Disclosure Policy – This time for M&A Lawyers

FDA Law Blog

By Anne K. Walsh — DOJ has issued another “voluntary disclosure” policy intended to encourage companies to disclose misconduct it discovers as part of a merger and acquisition. Under this new policy, a company will receive a “presumption of declination” of agency action – i.e., a safe harbor – if it discloses misconduct discovered at the acquired company within six months before or after closing.