FDA Law Blog

OCTOBER 16, 2023

By Gail H. Javitt & Steven J. Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The first article—“Is the Eye the Window to Alzheimer’s?

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East Cary Family Physicians

OCTOBER 20, 2023

Breast Cancer Awareness Month, celebrated every October, serves as a reminder of the significance of early detection, prevention, and support for those affected by breast cancer. At East Cary Family Physicians, we believe that knowledge is power. In this blog, we’ll explore the importance of Breast Cancer Awareness Month, focusing on early detection, prevention, and the vital role of regular screenings in women’s healthcare.

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Louisville Lectures

OCTOBER 18, 2023

Dr. Bryan Moffett presents "Sodium Derangements in the Medical Patient" by first differentiating the difference between total body sodium and sodium concentration. The then breaks down the physiology, causes, and treatment of hyponatremia. Watch the Video on YouTube Listen as a PodCast Watch Approach to Anemia and Acute and Chronic Diarrhea by Dr. Moffett BRYAN MOFFETT, M.D.

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The Clinical Problem Solvers

OCTOBER 18, 2023

[link] Sharmin , Jack, and Maddy discuss their approaches to severe acute liver injury, abdominal pain, and hyperferritinemia as they talk through a case presented by Ann-Marie. Frameworks: Severe Acute Liver Injury Abdominal Pain To join us live on Virtual Morning Report (VMR), sign up HERE.

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PEMBlog

OCTOBER 17, 2023

PEMPix is the American Academy of Pediatrics Section on Emergency Medicine’s annual visual diagnosis competition. This year, in addition to the 10 finalists Maneesha Agarwal will be presenting at the National Conference and Exhibition we will be sharing four cases online in advance of the conference. This is the second of the four cases. This case was submitted by… A 6-year-old previously healthy female was brought to your emergency department with extremity pain. 4 days earlier, she developed r

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FDA Law Blog

OCTOBER 18, 2023

By Adrienne R. Lenz, Principal Medical Device Regulation Expert — Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission. Such data may be needed to demonstrate substantial equivalence to a previously-marketed predicate device or, less frequently, to show that new or modified indications for use fall within the same intended use as the predicate device.

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GeriPal

OCTOBER 19, 2023

Summary Transcript Summary What level of evidence do we need for POLST to use it ourselves, to advocate for wider usage, and for establishing POLST completion as a quality metric? The answers to these questions will vary. Reasonable people will disagree. And today, on our podcast, our guests disagree. Firmly. AND we are delighted that our guests modeled respectful disagreement.

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PEMBlog

OCTOBER 18, 2023

PEMPix is the American Academy of Pediatrics Section on Emergency Medicine’s annual visual diagnosis competition. This year, in addition to the 10 finalists Maneesha Agarwal will be presenting at the National Conference and Exhibition we will be sharing four cases online in advance of the conference. This is the first of the four cases. This case was submitted by… A four-day-old, full-term, exclusively breastfed male with benign prenatal and antenatal courses, presented with one day of decreased

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PEMBlog

OCTOBER 16, 2023

EmergiQuiz is an annual case-based presentation sponsored by the AAP Section on Emergency Medicine that challenges the audience to think through the differential diagnosis for four amazing cases. Traditionally these cases are presented live at the AAP National Conference and Exhibition. Since 2020 the AAP Section on Emergency Medicine has also been sponsoring the publication of online cases on EmergiQuiz.com.

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FDA Law Blog

OCTOBER 19, 2023

By Larry K. Houck — Medicine cabinet, stuffed to the gills Capsules, liquid, patches, and pills Expired oxy, hydro, benzos, and more All kind of meds flowing out the door We will, we will, clear you We will, we will, clear you Were the Drug Enforcement Administration (“DEA”) a rock band, it might promote the upcoming National Prescription Drug Take Back Day by setting the lyrics above to a catchy tune.

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FDA Law Blog

OCTOBER 17, 2023

By Philip Won & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — On September 15, 2023, FDA released a final guidance document titled “Breakthrough Devices Program.” Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities and to certain non-addictive medical products to treat pain or addiction.

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PEMBlog

OCTOBER 19, 2023

PEMPix is the American Academy of Pediatrics Section on Emergency Medicine’s annual visual diagnosis competition. This year, in addition to the 10 finalists Maneesha Agarwal will be presenting at the National Conference and Exhibition we will be sharing four cases online in advance of the conference. This is the fourth of the four cases. This case was submitted by… A previously healthy 19-month-old male presented with lethargy and abdominal distention from an urgent care.

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