Myriad Genetics
MARCH 13, 2024
Many of us have seen stories in the news about American families on diagnostic odysseys for their children with rare diseases. Recently, the Today Show highlighted Courtney (she asked that only first names be used), who visited 17 different doctors over three years to help diagnose her young son Alex, who she was watching suffer and decline before her eyes.
GeriPal
MARCH 14, 2024
Summary Transcript Summary Almost a decade ago, our hospice and palliative care team decided to do a “Thickened Liquid Challenge.” This simple challenge was focused on putting ourselves in the shoes of our patients with dysphagia who are prescribed thickened liquids. The rules of the challenge were simple: fluids must be thickened to “honey consistency” using a beverage thickener for a 12-hour contiguous period.
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FDA Law Blog
MARCH 11, 2024
By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Allyson B. Mullen — On February 20, 2024, FDA issued a letter to the medical device industry ( link ) warning medical device firms of recent FDA concerns related to fraudulent and unreliable laboratory testing data in premarket submissions. Unfortunately, the letter provides little new information to guide industry conduct.
The Clinical Problem Solvers
MARCH 13, 2024
[link] Sharmin , Jack, and Youssef discuss their approach to joint pain as they reason through a case presented by Maddy. Monoarticular Arthritis Framework To join us live on Virtual Morning Report (VMR), sign up HERE.
PEMBlog
MARCH 12, 2024
New this year at the AAP NCE we will be hosting a brand new session that will highlight the talents of some of the very best educators in PEM. Faculty in the first ten years following training will be eligible to submit their very best presentation in any format on any topic Four finalists will present live at the NCE and compete for the title belt.
FDA Law Blog
MARCH 10, 2024
Last August the Food and Drug Administration (“FDA”)/Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By doing so, FDA/HHS believe that cannabis no longer meets schedule I criteria but does not meet schedule II criteria either.
FDA Law Blog
MARCH 12, 2024
By Sara W. Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately. As we explained in September 2023 , then again in November 2023 , the FTC has intervened in the matter and asked 10 drug companies (really 8 given common ownerships of some of the relevant companies) to delist about 100 patents from the Orange Book that mainly cover the device constituent
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