The Clinical Problem Solvers

JUNE 26, 2023

[link] CPSolvers: Anti-Racism in Medicine Series Episode 22 – Live from SGIM 2023: Best of Antiracism Research at the Society of General Internal Medicine’s 2023 Annual Meeting Show Notes by Alec J. Calac June 22, 2023 Summary : This episode highlights a selection of antiracism research presentations at a live recording of the podcast at the 2023 SGIM Annual Meeting.

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Vida Family Medicine

JUNE 29, 2023

Most patients who go to see a primary care doctor are concerned about improving their physical health. They want to live a long life free of chronic health problems that may cause pain, limit their activities, or cause complications that could land them in the hospital. There are many factors that impact our physical health- genetics, environmental exposures, economic resources, and behaviors.

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PEMBlog

JUNE 7, 2023

There are protocols in place that assist highly trained Emergency Medical Service providers in assuring that agitated children are safely transported to their destination. This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about what prehospital providers should do to get these agitated children safely to the ED.

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Plum Health

JUNE 29, 2023

Detroit Air Quality Update June 29th 2023 Unfortunately, today the air quality is 157 - 184, which is unhealthy. What is the typical air quality? The typical air quality index is closer to 30. This is an acceptable level of air quality where the air feels good, with no smoke, smog, or haze in the air. Visibility is good and asthma exacerbations happen with fewer frequency. what is the air quality like today?

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Hitchcock Family Medicine

JUNE 15, 2023

Getting constant headaches and feeling anxious can be related to a concerning case of stress. Most people have a basic understanding of what feeling stressed is or have experienced its symptoms once in their lifetime. However, as common as it is, it's a considerable mental health issue that affects those with a busy schedule or people with trauma. Stress also has countless misconceptions.

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Family Physicians of Greeley

JUNE 16, 2023

Navigating the complexities of insurance and healthcare costs can be overwhelming for patients. Understanding your insurance coverage, managing medical bills, and finding affordable healthcare options are essential for maintaining your health without breaking the bank. In this blog, we will provide you with practical tips to help you navigate insurance and healthcare costs effectively.

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The Clinical Problem Solvers

JUNE 15, 2023

[link] We continue our campaign to #EndNeurophobia, with the help of Dr. Aaron Berkowitz. This time, Dr. Gabriela Pucci presents a case of right arm weakness to Promise and Ravi. Promise Lee @promiseflee Promise Lee is currently a 3rd year medical student at Loyola University Chicago Stritch School of Medicine. She is an aspiring internal medicine physician with interests in GI, obesity medicine, public health, and clinical reasoning.

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PEMBlog

JUNE 27, 2023

It is summertime, so the bees and bugs are out! In this episode, Dr. Ben Grebber, a pediatric resident at Boston Children’s Hospital/Tufts Children’s Hospital, discusses Bee Stings and Spider Bites. A very common pediatric summer complaint in emergency departments, urgent cares, and primary care offices, this episode covers common signs and symptoms, some pathophysiology, and recommended treatments.

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Maine Academy of Family Physicians

JUNE 21, 2023

NEW June 21st -- UPDATE on DEA License Regulation Which Takes Effect on June 27th!

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Aspiring Minority Doctor

JUNE 18, 2023

Throwback to this time 5 years ago The other day I watched the residency graduation ceremony at the institution where I completed my Traditional Rotating Internship year. No, I wasn't trying to purposely torture myself.I was watching to support someone I know who was graduating from internship this year in the same program. The crazy thing is I didn't realize until I started watching that I was witnessing the graduation of several people who I started and worked with during my original intern ye

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FDA Law Blog

JUNE 27, 2023

HP&M’s James E. Valentine Named Top Lawyer Under 40; Only Food and Drug Lawyer Selected Hyman, Phelps & McNamara, P.C. (HP&M) is pleased to announce that Law360 has recognized one of our firm’s Directors, James E. Valentine , as a 2023 Rising Star. The honor was bestowed on only 183 attorneys, which is awarded to “top attorneys under 40 whose legal accomplishments belie their age.

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The Clinical Problem Solvers

JUNE 7, 2023

[link] Episode description: The spaced learning series team discusses a case of intermittent episodes of presyncope in a patient found to have hypoglycemia and polycythemia.

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University of Utah Family Medicine Residency

JUNE 21, 2023

by Matthew Demarco, MD As we come to the end of residency it is easy to immediately start looking forward to the next stage of life. It is so easy to be excited about what is to come including a new job, a new start, new opportunities.

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PEMBlog

JUNE 14, 2023

We are in the midst of a staggering mental health crisis. Thousands of children and adolescents spend days at time in Emergency Departments waiting for definitive mental health disposition. This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about what we should consider when boarding children in the ED for mental health reasons.

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GeriPal

JUNE 8, 2023

Summary Transcript Summary Diabetes is common. When I’m on nursing home call, the most common page I receive is for a blood sugar value. When I’m on palliative care consults and attending in our hospice unit we have to counsel patients about deprescribing and de-intensifying diabetes medications. Given how frequent monitoring and prescribing issues arise in the care of patients with diabetes in late life, including the end of life, Eric and I were excited when Tamryn Gray emailed us requesting

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Doctor On Demand

JUNE 21, 2023

Urinary tract infections (UTI) and yeast infections are two common and uncomfortable women’s issues you should know about. Even though these issues affect many women, most don’t talk openly about them. Whether you’ve had one of these issues before or never experienced either one, here are some basic tips on how you can identify what’s bothering you.

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FDA Law Blog

JUNE 27, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Anne K. Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ). FDA now seeks comments on this very program to support its continued collection of information as required under the Paperwork Reduction Act.

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The Clinical Problem Solvers

JUNE 19, 2023

[link] Dr. Kimberly Manning and her father, Mr. William Draper, commemorate Juneteenth, the holiday that celebrates the day when all remaining enslaved Black Americas were freed in Galveston Texas, on June 19 th , 1865, with this hour-long storytelling event.

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University of Utah Family Medicine Residency

JUNE 28, 2023

by Misha Fotoohi, MD I remember my first experience at Core Power Yoga (CPY) very distinctly. It was December 31st, and I had just finished a 28-hour shift in the Medical ICU at the University Hospital.

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FDA Law Blog

JUNE 26, 2023

By Faraz Siddiqui & Alan M. Kirschenbaum — As we and others closely following drug pricing have predicted, multiple additional lawsuits have followed in the wake of Merck’s challenge to the Inflation Reduction Act (IRA) price negotiation provisions in the D.C. federal district court on June 6 (see our post here ). Since then, complaints have been filed in federal court in Ohio by the U.S.

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FDA Law Blog

JUNE 22, 2023

By McKenzie E. Cato & Jeffrey N. Gibbs & Allyson B. Mullen — FDA has been clearing over-the-counter (OTC) in vitro diagnostic (IVD) tests nearly since the beginning of its premarket regulation of devices. The first OTC IVD cleared by FDA was a qualitative dipstick urine glucose test in 1977, followed shortly thereafter by the first OTC pregnancy test clearance in 1978.

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FDA Law Blog

JUNE 5, 2023

By Allyson B. Mullen — FDA recently released further updates to the Customer Collaboration Portal (“CCP”). Readers of the blog will know that I am a HUGE fan of the CCP (see our earlier posts here and here ). It has made filing of all premarket submissions much easier by facilitating a direct upload of the submission to FDA. The CCP has also allowed industry the ability to track the status of 510(k) submissions.

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FDA Law Blog

JUNE 8, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. Department of Health and Human Services declared the long-awaited end of the federal COVID-19 Public Health Emergency. The pandemic had changed the way people live, work and communicate. Such changes are not limited to personal circumstances. The pandemic also deeply impacted how industry and the government conduct their operations.

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FDA Law Blog

JUNE 28, 2023

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions. Use of voluntary consensus standards can reduce regulatory burden, streamline conformity assessment, harmonize requirements globally, and enhance the quality and safety of a device.

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The Clinical Problem Solvers

JUNE 19, 2023

[link] Episode description RR discuss a grounding case of chest pain Student discount [link] IMG discount Use coupon code RLRIMG at check out [link]

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FDA Law Blog

JUNE 28, 2023

By Riëtte van Laack — On June 8, 2023, bipartisan legislation creating a new category of animal feed ingredients, named zootechnical animal food substances, was introduced. This legislation, named the Innovative Feed Enhancement and Economic Development Act (Innovative FEED Act) , is an effort to create an approval process for ingredients with environmental or food safety claims as food additives rather than as animal drugs.

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FDA Law Blog

JUNE 21, 2023

By Philip Won & McKenzie E. Cato — On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. According to the announcement, enabling patients to access medical devices beyond traditional clinical settings can help close the healthcare gap by delivering care “directly to patients, wherever they are – at home, at work, in cities,

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FDA Law Blog

JUNE 20, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Allyson B. Mullen — On June 2, 2023, FDA issued the latest version of its guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry.

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FDA Law Blog

JUNE 16, 2023

By Sophia R. Gaulkin & Alan M. Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. The drug pricing provisions of SF 2744 establish two mechanisms intended to curb rising drug costs: (1) a prohibition on generic drug manufacturers from taking price in

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FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.

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FDA Law Blog

JUNE 7, 2023

By Faraz Siddiqui & Alan M. Kirschenbaum — The Inflation Reduction Act’s price negotiation program for drugs covered under Medicare Parts B and D (“Negotiation Program”) has been challenged in federal court. Yesterday, Merck filed a complaint in the D.C. District Court challenging the Negotiation Program as a “sham,” an “extortion,” and a violation of the First and Fifth Amendments to the Constitution.

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FDA Law Blog

JUNE 5, 2023

By Dara Katcher Levy — The Academy of Managed Care Pharmacy (AMCP)’s Format Executive Committee is excited to let you know that after two years of work, version 5.0 of the Format for Formulary Submissions (also known as dossiers) is on the horizon. And we need your feedback! We’ve included revisions to the Format in key areas related to digital therapeutics, health disparities, streamlining dossiers, as well as AMCP guidance on Pre-Approval Information Exchange (PIE) decks.

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FDA Law Blog

JUNE 11, 2023

By Mark A. Tobolowsky & David B. Clissold — In May 2023, CDER and CBER published a draft guidance titled “Pediatric Drug Development: Regulatory Considerations – Complying with the Pediatric Research Equity Act [“PREA”] and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act [“BPCA”]” (the “Draft Guidance”). This Draft Guidance, in part, replaces a 2005 guidance titled “How to Comply with the Pediatric Research Equity Act.

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FDA Law Blog

JUNE 7, 2023

By John W.M. Claud & Faraz Siddiqui — As we move into the heat of the summer, we can look forward to the annual June deluge of opinions coming from the Supreme Court. Last week, the Court ruled on a pair of combined cases that potentially impacts many of our blog readers in the pharmaceutical, device, and biologics space that benefit from reimbursements from Federal health care programs.

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GeriPal

JUNE 15, 2023

Summary Transcript Summary Artificial Intelligence, or AI, has tremendous potential. We talk on this podcast about potential uses of AI in geriatrics and palliative care with natural language processing guru Charlotta Lindvall from DFCI, bioethicists and internist Matt DeCamp from University of Colorado, and prognosis wizard Sei Lee from UCSF. Social companions to address the epidemic of loneliness among older adults Augmenting ability of clinicians by taking notes Searching the electronic heal

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GeriPal

JUNE 22, 2023

Summary Transcript Summary In the early 1990’s, California Medical Facility (CMF) created one of the nation’s first licensed hospice units inside a prison. This 17-bed unit serves inmates from all over the state who are approaching the end of their lives. A few are let out early on compassionate release. Many are there until they die. Today’s podcast is part one of a two-part podcast where we spend a day at CMF, a medium security prison located about halfway between San Francisco and Sacram

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GeriPal

JUNE 29, 2023

Summary Transcript Summary I don’t know ’bout religion I only know what I see And in the end when I hold their hand It’s both of us set free These are the ending lyrics to Bonnie Raitt’s song “Down the Hall”, an ode to the Pastoral Care Workers who care for their fellow inmates in the hospice unit at the California Medical Facility in Vacaville, California.

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