Sat.Apr 27, 2024 - Fri.May 03, 2024

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Episode 332: Schema Episode – Splenic Lesion

The Clinical Problem Solvers

[link] Maddy , Jack, and Sharmin share their approach to focal splenic lesions and splenic infarcts as they discuss a case presented by Youssef. Frameworks Discussed in Case: Focal Splenic Lesion Splenic Infarct Splenic Infarct vs Abscess To join us live on Virtual Morning Report (VMR), sign up HERE.

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FDA’s Draft Guidance on the Q-Submission Program – A Step in the Wrong Direction

FDA Law Blog

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert — FDA recently issued a draft guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program , which included some changes over the existing guidance which could have a negative impact on future pre-submissions. The draft guidance attempted to clarify when a Sponsor’s question may be more appropriate for more informal communication.

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Medicare Part D Price Negotiations - Clinical Correlations

Clinical Correlations

By Alison Cline Peer Reviewed Let’s Start with a Case… A 79-year-old man with a history of atrial fibrillation and stroke presents to the emergency department with new focal neurologic deficits in the setting of a recent upper.

Clinic 52
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Happy 17th Anniversary to my Amazing Wife!

PEMBlog

The only annual “non-medical” post to PEMBlog is here. My annual anniversary video that I produce for my wife. Ok, so it has become clear by now that I’m having difficulty making it to Hallmark to buy an appropriate anniversary card. Are there any stores still open in the Greater Cincinnati area? I’m not sure anymore. I need to own up to my failures.

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Conflicts, Corruption, Medicine, and Me Part IV

Evergreen Family Medicine

It’s easier to fool people than to convince them that they have been fooled.Mark Twain It is fitting that my final installment of this series has its focus on the last word of my title. Me. Pointing out corruption, financial or political influence, and bias arising from self-interest of corporations, institutions, and journals is important and true.

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Sarah Wicks Returns to HPM to Elevate Drug Development and Regulatory Practice

FDA Law Blog

Hyman, Phelps & McNamara, P.C. proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of product development and commercialization. Her expertise spans a range of critical areas including: human subject protections, clinical trial conduct, development strategies, FDA interactions, and enforcement action r

Clinic 52
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Democratic Lawmakers Advocate for Prompt Decontrol of Marijuana

FDA Law Blog

By Larry K. Houck — On April 23, 2024 we blogged about Republican Senators Mitt Romney, Pete Ricketts and James Risch advising Drug Enforcement Administration (“DEA”) Administrator Anne Milgram to consider U.S. treaty obligations under the Single Convention, 1961, when rescheduling marijuana. Later Democratic lawmakers, eleven senators and ten members of Congress, also penned a letter to Administrator Milgram and Attorney General Merrick Garland imploring DEA to not only “promptly remove mariju

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