Intuitive Intelligence

JANUARY 3, 2024

As we usher in the new year, many of us embark on a journey of self-improvement, setting resolutions that promise a better version of ourselves. However, have you ever wondered why these resolutions often fizzle out before the first quarter ends? The missing link might be aligning your goals with your unique work style. I recently had the opportunity to explore this concept in an article published on Fast Company titled, “ How to Ace Your New Year’s Resolution and Upgrade Your Life.”

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Noreta Family Medicine

JANUARY 29, 2024

How to Get Rid of Old/Unused Medicines How many unused or expired medicines do you have in your house? It’s ok to admit it. As a family doctor, I hear my patients talk about their “medicine cabinet full of old medicines” all the time. By reading this blog, I hope you will learn why it’s important to not only get rid of those old medicines but how to get rid of them properly.

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Boulder Medical Center

JANUARY 28, 2024

Dr. Jennifer Beck, a board-certified orthopedic surgeon and sports medicine specialist, outlines some common causes and types of pickleball injuries and guides when to seek medical assistance. The post Preventing Pickleball Injuries appeared first on Boulder Medical Center.

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Louisville Lectures

JANUARY 31, 2024

Audry Hawkins is back to discuss antimicrobial stewardship in pneumonia. She starts with comparing differences in guidelines and recent primary literature on empiric treatment of pneumonia. Hawkins then evaluates appropriate empiric step-down therapy and durations and after, discusses the nuances in guideline recommendations for pneumonia. Watch on YouTube Listen as a Podcast Watch more lectures about Internal Medicine Audry Hawkins, PharmD, BCIDP Infectious Diseases Clinical Specialist Pharmacy

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Oasis Family Medicine

JANUARY 31, 2024

While we have had neurofeedback therapy available at Oasis Family Medicine since 2017, it is always our goal to offer the most up-to-date therapies available. The previous neurofeedback system we had was a good one, but it became more difficult to manage, so it became obvious that it was time to find a different option. I went on a year-long search for a new (and hopefully better) neurofeedback system.

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FDA Law Blog

JANUARY 15, 2024

By David B. Clissold & Sara W. Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. To quote the Fifth Circuit: “It was the regulatory equivalent of Romeo sending Mercutio on a wild goose chase—and then admitting there never was a goose while denying he even suggested the chase.

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The Clinical Problem Solvers

JANUARY 17, 2024

[link] Episode title: Episode 317: Neurology VMR – Generalized weakness Episode description: We continue our campaign to #EndNeurophobia, with the help of Dr. Aaron Berkowitz. This time, Kirtan presents a case of generalized weakness to Vivek and Hannah. Neurology DDx Schema Kirtan Patolia @KirtanPatolia Kirtan Patolia is a second-year Internal Medicine resident from John H.

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PEMBlog

JANUARY 3, 2024

This is an amazingly well-done infographic/video I found on Reddit of all places. I am working on finding out the source author – stay tuned.

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GeriPal

JANUARY 25, 2024

Summary Transcript Summary In a JAMA 2020 systematic review of palliative care for non-cancer serious illness, Kieran Quinn found many positives, as we discussed on our podcast and in our editorial. He also found gaps, including very few studies of patients with lung disease, and little impact of trials on quality of life. The article we discuss today, also published in JAMA , addresses these two gaps.

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Family Physicians of Greeley

JANUARY 9, 2024

Adolescent medicine is a sub-specialty of family medicine and pediatrics, that focuses on the health issues of youths from ages 9 through 23. At times, the healthcare that many of these youths receive begins and ends with their yearly sports physical. And while this is a good start, thorough healthcare during these years is so much more than simply a yearly physical, including puberty, mental health, along with social and emotional development.

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FDA Law Blog

JANUARY 8, 2024

By John W.M. Claud — As the calendar turned to 2024, we came across the usual end-of year looks back and projections ahead. Our feed saw a number of rosy forecasts for mergers and acquisitions in FDA-regulated industries. Interest rates may be on the way down, which in turn may mean that more capital will free up and thus more deals may be in the offing.

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The Clinical Problem Solvers

JANUARY 30, 2024

[link] In this Rheumatology Rafael Medina Subspecialty episode, Dr. John Landefeld presents a case to Dr. Sarah Goglin of a 74 year old woman presenting with headache. Session facilitator: Şeyma Yıldırım The goal of this session is to expand access to subspecialty, primary care, and internal medicine-adjacent specialty education to learners around the world.

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FDA Law Blog

JANUARY 28, 2024

By Jeffrey N. Gibbs & Steven J. Gonzalez — In a new publication in the Washington Legal Foundation’s (WLF) Legal Backgrounder , we argue that FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs) is vulnerable to legal challenge, once finalized. FDA’s proposed rule has every hallmark of a case subject to the “major questions doctrine,” according to which agency action must be support by clear congressional authorization.

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FDA Law Blog

JANUARY 24, 2024

The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp”—now in its 42nd iteration—is scheduled to take place from March 13-14, 2024, at the SpringHill Suites NY Manhattan Times Square South, New York. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. For nearly 20 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA la

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FDA Law Blog

JANUARY 22, 2024

By John W.M. Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. OCs recent 2023 Annual Report—covering the fiscal year from October ’22 to September ’23—puts some meat on the bones of those issues and describes how OC touches almost every area of enforcement that CDER undertakes.

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FDA Law Blog

JANUARY 18, 2024

By John W.M. Claud & Sara W. Koblitz & Karla L. Palmer — A new lawsuit against FDA is the latest happening in the veterinary drugs space and, by extension, FDA’s Center for Veterinary Medicine (CVM). We blogged about CVM last week and explained the increasing attention to animal health products due to the expansion of the animal and pet product market.

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FDA Law Blog

JANUARY 11, 2024

Two Hyman, Phelps & McNamara, P.C. (HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, Puerto Rico. This day-long (FREE) seminar is a must-attend event for anyone in the pharmaceutical sector interested in understanding the “ins and outs” of doing business in the Territory, as well as an opportunity to interact with those who already have a keen understanding of

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FDA Law Blog

JANUARY 11, 2024

By Sara W. Koblitz — Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”). As has been explained, the BPCIA provided an abbreviated pathway to market for follow-on biologics—biosimilars and interchangeable biosimilars—and with that pathway came two types of exclusivity periods: one for the “Reference Product” to encourage continued innovation and one for the

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FDA Law Blog

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and di

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The Clinical Problem Solvers

JANUARY 10, 2024

[link] New Year, old episode! Rabih and Reza reveal all of the math and magic behind becoming better learners. Join live morning reports here!

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GeriPal

JANUARY 18, 2024

Summary Transcript Summary The CDC’s Guideline for Prescribing Opioids for Chronic Pain excludes those undergoing cancer treatment, palliative care, and end-of-life care. In doing so, it seems to give the impression that pain seen in cancer is inherently different than pain seen in other conditions and that those with cancer may not have the same risk for opioid use disorder as compared to other conditions.

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GeriPal

JANUARY 11, 2024

Summary Transcript Summary Four percent of deaths in Canada are due to Medical Assistance in Dying (MAID). Four percent. The number of people who have used MAID in Canada since it was legalized in 2016 has increased year on year from about 1,000 people in the first year to over 13,000 people in 2022. California, which has a similar population size as Canada and legalized MAID around the same time, has fewer than 1000 deaths per year from MAID.

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FDA Law Blog

JANUARY 18, 2024

By Larry K. Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By doing so, FDA determined that marijuana not only no longer meets schedule I criteria, but by leapfrogging to schedule III, concluded that it does not meet schedule II criteria either.

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FDA Law Blog

JANUARY 1, 2024

By Douglas B. Farquhar & Aisha T. Evans* & Irene Namata* — Primacy and recency are recognized psychological phenomena: people tend to remember the first thing they hear, and the last. It’s why litigators concentrate on their opening statement to a jury, and their closing argument. Maybe that’s also why FDA last week publicized the highest number of important Warning Letters of the year (compared with prior releases in 2023).

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FDA Law Blog

JANUARY 7, 2024

By McKenzie E. Cato — New Year’s is often associated with baby New Year and with resolutions, which in a convoluted way got us thinking about post-approval pregnancy studies. Lots of us start the new year with a resolution. Is it a commitment, or a requirement, and does the difference matter? For post-approval pregnancy studies, it most certainly does.

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FDA Law Blog

JANUARY 3, 2024

By Sara W. Koblitz & Karla L. Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. With the growth in pet ownership, the pet health product market has also exploded; a Bloomberg article from March 2023 noting that the growth in the pet industry market “is driven by an increase in spending on pet-related healthcare—including veterinary care, diagnostic

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FDA Law Blog

JANUARY 24, 2024

By Kurt R. Karst — In September 2022, while the world was still in the midst of the COVID-19 epidemic and dealing with significant supply chain woes, President Biden issued an Executive Order— Executive Order 14081 —titled “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” Section 1 of the Executive Order laid out the Biden Administration’s policy to, among other things, “coordinate a whole-of-government approach to advance biotech

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PEMBlog

JANUARY 17, 2024

This episode will help you recognize cellulitis and even differentiate it from erysipelas which is totally a different thing. You’ll also learn about treatment, whether or not a blood culture is necessary, and a whole lot more. @PEMTweets on… sigh “X” (Twitter) My Instagram My Mastodon account @bradsobo Listen [link] Subscribe References Chen AE, Carroll KC, Diener-West M, Ross T, Ordun J, Goldstein MA, Kulkarni G, Cantey JB, Siberry GK.

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FDA Law Blog

JANUARY 9, 2024

By Faraz Siddiqui & Alan M. Kirschenbaum — The law permitting the importation of cheaper prescription drugs from Canada—Section 804 of the Federal Food, Drug, and Cosmetic Act (FDC Act)—has been on the books for decades. After its enactment in 2003, successive administrations thwarted its implementation by declining to certify to Congress that importation will pose no additional risk to public health and safety and will result in a significant reduction in cost to American consumers, as the

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