Louisville Lectures

AUGUST 25, 2023

In this presentation, Dr. Ryan Doster gives an introduction to diagnostic stewardship after last week's discussion on antimicrobial stewardship. After, Audry Hawkins, PharmD, BCIDP, returns to give an overview on blood culture. Click here for a lecture on Antimicrobial Stewardship. Watch on YouTube Listen as a Podcast Watch more lectures about Internal Medicine Audry Hawkins, PharmD, BCIDP Ryan Doster, M.D., Ph.d.

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FDA Law Blog

AUGUST 24, 2023

Hyman, Phelps & McNamara, P.C. (“HP&M”) is is proud to announce that 14 of the Firm’s attorneys have been selected to the 2024 edition of The Best Lawyers in America®. Newly recognized this year are attorneys Josephine M. Torrente (FDA Law), Michelle L. Butler (FDA Law), Sara W. Koblitz (FDA Law), Allyson B. Mullen (FDA Law), and Anne K. Walsh (FDA Law), as well as McKenzie E.

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The Clinical Problem Solvers

AUGUST 23, 2023

[link] Jack, AMK , and Maddy discuss their approaches to cytopenias and DVTs as they talk through a case presented by Sharmin. Frameworks: Pancytopenia Thrombocytopenia Download CPSolvers App here RLRCPSOLVERS Click here to view the weekly episode recap email!

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Plum Health

AUGUST 20, 2023

Dr. Paul Thomas Gives the Welcome to Detroit Lecture for Incoming Class of 2027 at WSU SOM This year, Dr. Paul Thomas was invited to give a “Welcome to Detroit” lecture for the Wayne State University School of Medicine Class of 2027. These medical students will be immersed in the Detroit community over the next 4 years, and upon graduation, many of them will continue to serve the Detroit and Metro Detroit community.

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GeriPal

AUGUST 24, 2023

Summary Transcript Summary I hear the word dignity used a lot in the medical setting, but I’m never sure what people mean when they use it. You’d imagine that as a seasoned palliative care doc, I’d have a pretty good definition by now of what “maintaining dignity” or “loss of dignity” means, but you’d be sadly wrong. Well that all changes today as we’ve invited the world’s foremost expert in dignity at the end of life, Dr.

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FDA Law Blog

AUGUST 23, 2023

By Adrienne R. Lenz, Principal Medical Device Regulation Expert — As part of FDA’s Prescription Drug User Fee Act (PDUFA) VII goals published in PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027 (PDUFA Goal Letter), which we blogged about here , FDA included a goal for enhancing use of digital health technologies (DHT) to support drug development and review.

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East Cary Family Physicians

AUGUST 24, 2023

Participation in sports and physical activities offers numerous benefits, from improved cardiovascular health to enhanced mental well-being. To ensure a safe and healthy experience, it’s crucial to prioritize sports physicals for athletes of all ages. As your trusted family physicians, we understand the significance of ensuring your child’s health and safety before they dive into the world of school sports and physical activities.

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FDA Law Blog

AUGUST 21, 2023

By Larry K. Houck — Last week the U.S. Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act (“CSA”). Austin Pharmacy to Pay $200,000 in Civil Penalties for Alleged Violations of the Controlled Substances Act, Aug. 16, 2023 ( DOJ Press Release ).

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FDA Law Blog

AUGUST 22, 2023

By Dara Katcher Levy — OPDP is coming out ! On the heels of a nuanced and more complicated Warning Letter addressing CFL claims and statistical presentations comes a new Untitled Letter from OPDP going back to its roots ! This most recent Untitled Letter to Exeltis alleges omission of risk information as well as misleading efficacy information in a promotional social media post and Exeltis’s failure to submit on 2253.

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FDA Law Blog

AUGUST 21, 2023

By Sara W. Koblitz & Deborah L. Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. While it has been long established that FDA-approved or mandated labeling preempts state failure-to-warn claims, some courts have decided that sometimes labeling just isn’t enough, never mind what FDA thinks.

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