Sat.May 18, 2024 - Fri.May 24, 2024

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Learn CPR!

Noreta Family Medicine

Learn CPR! I recently organized several CPR classes for Noreta Family Medicine patients as well as their family and friends. Damar Hamlin’s collapse during an NFL game in January 2023 inspired me to want to hold these CPR classes (although I admit it took a while to arrange!). It was the immediate on-field medical attention that Damar Hamlin received that saved his life, and that is no exaggeration.

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Episode 336 – Clinical Unknown – Mark, Noah & Yazmin discuss Nidhi’s case

The Clinical Problem Solvers

[link] In this episode, the team from The CPSolvers Academy participated in a fantastic discussion. Nidhi presented a case to Mark, Noah, & Yazmin. Embark on this diagnostic journey with us!

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

FDA Law Blog

By Jeffrey N. Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — We recently blogged about the Center for Devices and Radiological Health’s (CDRH) reluctance to make full use of real-world data (RWD) and real-world evidence (RWE) to support marketing applications. In response to the post, we did receive feedback from a company that had had the good fortune to have very positive experiences with RWD/RWE.

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Medical Music Mondays: Tick, Tick, Boom!

PEMBlog

Lyme disease has 3 stages. I have a hard time remembering them. Perhaps some pop punk will help? Learn about Early, Early disseminated, and Late Lyme. And remember, It’s Doxycycline Time! Lyrics [Chorus] Tick, Tick, Tick, Tick, BOOM! It’s Lyme! Doxycycline Time! Tick, Tick, Tick, Tick, BOOM! [Verse] Early disease is just one E M lesion Maybe one tick bite in the warm season Early disseminated is worse, I’ll confide this More rash, neuro stuff, and carditis Late disease joints r

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Upcoming EveryLife Foundation Scientific Workshop on May 21, 2024 will Address Challenges in Developing Therapies for Ultra-Rare Diseases

FDA Law Blog

By Sarah Wicks — On May 21, 2024, the EveryLife Foundation for Rare Diseases (ELF) will host a Scientific Workshop at the National Press Club in Washington, D.C. aimed at identifying and characterizing the challenges in developing therapies for ultra-rare diseases and conditions that affect exceedingly small populations. The workshop will drive in-depth discussions from leaders across federal agencies, the patient advocacy community, industry, academia and policy to examine the current state of

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House and Senate Members Introduce Long-Shot Resolutions to Repeal FDA’s LDT Final Rule

FDA Law Blog

By Steven J. Gonzalez — On May 15th and 16th, respectively, Senator Rand Paul and Congressmen Brad Finstad and Dan Crenshaw introduced Senate and House resolutions “providing for congressional disapproval under chapter 8 of title 5, United States Code” of FDA’s Final Rule to regulate Laboratory Developed Tests (LDTs). These resolutions are the first step in the (unlikely) process to repeal FDA’s Final Rule using the Congressional Review Act (CRA).

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Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog

By Larry K. Houck — Last August Health and Human Services (“HHS”) recommended rescheduling marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.