Intuitive Intelligence

SEPTEMBER 7, 2023

In the world of leadership and corporate dynamics, there’s often more than meets the eye. Today, we’re embarking on a journey of discovery that unravels the intricate connections between corporate conflict resolution and the uniqueness of your leadership style. Brace yourself for a thought-provoking exploration. Conflict: The Emotional Rollercoaster Picture this: You’re seated in a high-stakes corporate meeting, surrounded by your team and senior executives.

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Vida Family Medicine

SEPTEMBER 8, 2023

September is Polycystic Ovarian Syndrome (PCOS) Awareness Month. This condition is common in general, but it is something I see particularly frequently in my practice. There is a lot of misinformation on the internet and on social media about this condition, so I wanted to share more information to help better explain this condition and what it means.

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PEMBlog

SEPTEMBER 20, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not. The Choosing Wisely Pediatric Emergency Medicine Recommendations The Choosing Wisely Campaign Toolkit Expert Contributors Kelly Levasseur, DO Children’s Hospital of Michigan Detr

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The Clinical Problem Solvers

SEPTEMBER 20, 2023

[link] Sharmin & Kaylin are joined by María Jimena Alemán, CPSolvers co-director of internal operations & future neurologist with a passion for global health. They discuss how her upbringing has informed & shaped her passions & values, how she got involved with CPSolvers, the growth that comes from being a leader, the power of community & good mentor-mentee relationships.

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Louisville Lectures

SEPTEMBER 11, 2023

Dr. Ben Rogers presents a lecture on reflux by discussing a classic presentation of reflux as well as testing. Dr. Rogers emphasizes modifying care and diagnosis towards each patient with their own unique symptoms. Watch on YouTube Listen as a Podcast Watch more Lectures from the gastroenterology & hepatology Bengamin D. Rogers, m.d., m.s. Dr. Ben Rogers is an Assistant Professor of Medicine at the University of Louisville.

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FDA Law Blog

SEPTEMBER 19, 2023

By Sara W. Koblitz & Kurt R. Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. On the heels of its powerful (and unprecedented) amicus brief in Paragraph IV litigation between Jazz and Avadel concerning a patent covering a Risk Evaluation and Mitigation Strategy (“REMS”) listed in the Orange Book, the Federal Trade Commission (“FTC”) is gearing up to tackle anticompetitive Orange Book listing practices.

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OCFM

SEPTEMBER 20, 2023

Osteopathic Center for Family Medicine Home Direct Primary Care - FAQs Documents, Links and Tools Documents Links Tools About us Family Medicine Osteopathy Prolotherapy Nudge360 Who we are Directions Contact Us Blog Osteopathic Center for Family Medicine Home / Direct Primary Care - FAQs / Documents, Links and Tools / Documents Links Tools About us / Family Medicine Osteopathy Prolotherapy Nudge360 Who we are Directions Contact Us / Blog / Osteopathic Center for Family Medicine Family Medicine U

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PEMBlog

SEPTEMBER 29, 2023

Did you know that there are comprehensive respiratory viral panels that will test for dozens of viruses all at once? Did you know that these tests are very expensive, and that they rarely alter management? Did you know that Choosing Wisely recommends that we do not routinely obtain them for respiratory viral illnesses? Of course you did, but that doesn’t mean you shouldn’t watch this entertaining video that I made with Dr.

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The Clinical Problem Solvers

SEPTEMBER 5, 2023

[link] In this Gastroenterology Rafael Medina Subspecialty episode, Dr. Allyson Richardson presents a case to Dr. Ryan Flanagan of a 68 year old woman presenting with chronic diarrhea. 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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GeriPal

SEPTEMBER 7, 2023

Summary Transcript Summary The comprehensive geriatric assessment is one of the cornerstones of geriatrics. But does the geriatric assessment do anything? Does it improve outcomes that patients, caregivers, and clinicians care about? Evidence has been mounting about the importance of the geriatric assessment for older adults with cancer, the subject of today’s podcast.

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FDA Law Blog

SEPTEMBER 27, 2023

By James E. Valentine & Mark A. Tobolowsky — Much has changed since the long-gone days of 2017. The Washington Nationals won the World Series, Presidential administrations have come and gone, and FDA has added new meeting types and formats to its menu. And so, FDA has issued a new draft guidance to bring everyone up to speed on formal meetings under PDUFA.

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FDA Law Blog

SEPTEMBER 15, 2023

On September 18-20, Informa Connect will hold its annual #MDRPSummit in Chicago (and via livestream) to discuss the complex, ever-evolving laws and regulations in the government pricing and price reporting space. This three-day summit will feature numerous presentations, workshops and networking opportunities featuring government officials, drug pricing and reimbursement lawyers and experts and industry leaders.

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FDA Law Blog

SEPTEMBER 11, 2023

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health.

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FDA Law Blog

SEPTEMBER 29, 2023

By McKenzie E. Cato & Allyson B. Mullen & Gail H. Javitt — It’s the moment we’ve all been waiting for , dreading , anticipating. Today, FDA released a copy of a proposed rule to regulate laboratory-developed tests (LDTs), which is scheduled to be published in the Federal Register on October 3rd. The proposed rule has a 60-day comment period for stakeholders.

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FDA Law Blog

SEPTEMBER 26, 2023

Hyman, Phelps & McNamara, P.C. (HP&M), a leader in providing legal and regulatory support to the life sciences industries, today announced the appointment of Jeff Grizzel to the newly created position of Chief Marketing Officer (CMO). Grizzel will oversee the marketing organization, with responsibility for continuing and enhancing HP&M’s brand and expanding its business development activities.

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FDA Law Blog

SEPTEMBER 24, 2023

By Faraz Siddiqui — Every parent is familiar with the parade of horrors that accompany household items as mundane as window coverings. The cords that dangle from blinds are universally recognized as a grave danger to infants and children. It is also a hot-button issue for the U.S. Consumer Product Safety Commission (CPSC), the federal agency charged with monitoring and enforcing against dangerous consumer products.

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FDA Law Blog

SEPTEMBER 17, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — Over the last three and a half years, meetings with FDA were conducted virtually. During this time, CDRH moved from Webex to Zoom and gained experience with the virtual platform. Now, in addition to engaging with FDA via Zoom, medical device sponsors can once again engage in in-person meetings with the Agency.

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FDA Law Blog

SEPTEMBER 28, 2023

On October 11th, Hyman, Phelps & McNamara, P.C. Director Deborah Livornese will join Faber Deaufur & Itrato Principal Jill Alvarez and Counsel Heather Centauro, and Helen Hemley at Mass General Hospital, for a discussion on diversity in clinical trials, and the implications of the new federal guidelines under the Food and Drug Omnibus Reform Act of 2022 (“FDORA”), which was passed as part of the Consolidated Appropriations Act, 2023 , Pub.

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FDA Law Blog

SEPTEMBER 28, 2023

By JP Ellison & Anne K. Walsh — As readers of the FDA Law Blog know, the FDC Act is a strict liability criminal enforcement statute that can impose criminal misdemeanor penalties on a person without any showing of intent. See some of our prior posts, here , here , and here. If committed with an intent to defraud or mislead, an FDC Act violation can become a felony, which carries more significant jail time and financial penalties.

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PEMBlog

SEPTEMBER 27, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not. The Choosing Wisely Pediatric Emergency Medicine Recommendations The Choosing Wisely Campaign Toolkit Expert Contributors Olivia Ostrow, MD Hospital for Sick Children Toronto, Ontario,

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PEMBlog

SEPTEMBER 22, 2023

For most children with children with constipation an abdominal X-Ray will not assist in making the diagnosis or quantifying the exact stool burden. @WilltheThrill2 made a special video that helps to answer the question. And yes, he’s my son. Enjoy!

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PEMBlog

SEPTEMBER 15, 2023

Did you know that lab tests and CT scans are not recommended for most children who fully recover after a simple febrile seizure or a first-time, unprovoked generalized seizure? Choosing Wisely recommends that doctors and all medical providers have detailed conversations with patients and their families about why labs and CT scans are unlikely to give new information or provide any additional reassurance.

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The Clinical Problem Solvers

SEPTEMBER 13, 2023

[link] Episode description Reza and Rabih discuss a curious case of Anasarca Student discount [link] IMG discount Use coupon code RLRIMG at check out [link]

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PEMBlog

SEPTEMBER 13, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not. The Choosing Wisely Pediatric Emergency Medicine Recommendations The Choosing Wisely Campaign Toolkit Expert Contributors Paul Mullan, MD Children’s Hospital of the King’s Daughters No

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PEMBlog

SEPTEMBER 6, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not. The Choosing Wisely Pediatric Emergency Medicine Recommendations The Choosing Wisely Campaign Toolkit Expert Contributors Shabnam Jain, MD, MPH Emory University/Children’s Healthcare o

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PEMBlog

SEPTEMBER 1, 2023

Did you know that chest X-Rays are not recommended for most children with respiratory problems such as bronchiolitis, asthma exacerbations, croup, or first-time wheezing. Choosing Wisely recommends that doctors and all medical providers have detailed conversations with patients and their families about why X-Rays are unlikely to give new information or provide any additional reassurance.

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PEMBlog

SEPTEMBER 1, 2023

Repetitive Read Syndrome is affecting Radiologists across the globe. Symptoms include dictations including the same phrasing and suggesting clinical correlation repeatedly. We can help our Radiology colleagues by avoiding unnecessary chest X-ray orders for most children with respiratory problems such as bronchiolitis, asthma exacerbations, croup, or first-time wheezing.

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FDA Law Blog

SEPTEMBER 6, 2023

By Douglas B. Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S. Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. Many of our clients have been confounded by their inability to secure a change in the classification of the facility, or to convince FDA to meet with representatives of the own

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GeriPal

SEPTEMBER 28, 2023

Summary Transcript Summary Medical communication is tough, although fundamentally at its most basic unit of delivery, it includes really only three steps. First, a clinician’s thoughts must be encoded into words, then transmitted often via sounds, and finally decoded back to thoughts by a patient or family member. Simple, right? Not so much, as each one of these steps is fraught with miscommunication.

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FDA Law Blog

SEPTEMBER 10, 2023

By Mark A. Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program. This finalized a draft guidance issued in December 2021, largely similar in substance.

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FDA Law Blog

SEPTEMBER 5, 2023

By Larry K. Houck — Scheduling Criteria Under the Controlled Substances Act (“CSA”) Schedule I: • High potential for abuse; • No currently accepted medical use in treatment in the U.S.; and • Lack of accepted safety for use under medical supervision. 21 U.S.C. § 812(b)(1). Schedule III: • Potential for abuse less than drugs or substances in schedules I and II; • Currently accepted medical use in treatment in the U.S.; and • Abuse may lead to moderate or low physical dependence or high psycholog

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GeriPal

SEPTEMBER 21, 2023

Summary Transcript Summary The proportion of people living with dementia who identify as Black/African Americans is on the rise , and so too are the proportion of caregivers who identify as Black/African American. As our guests talk about today, caregiving for people living with dementia takes a tremendous toll, and when this toll is set atop the challenges of racism in all its forms, the reality of caregiving while Black can be overwhelming.

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PEMBlog

SEPTEMBER 8, 2023

Did you know that screening laboratory tests in the medical clearance process of pediatric patients who require inpatient psychiatric admission are not recommended unless clinically indicated? This video discusses why we don’t need labs for most children and adolescents who are being admitted to an inpatient mental health facility via an admittedly silly (but representative) conversation.

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FDA Law Blog

SEPTEMBER 12, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing. Non-compliant facilities face: Increased patient and employee health risks — in some cases even overdose deaths Multi-million-dollar settlements — and these amounts hav

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FDA Law Blog

SEPTEMBER 26, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing. Non-compliant facilities face: Increased patient and employee health risks — in some cases even overdose deaths Multi-million-dollar settlements — and these amounts hav

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GeriPal

SEPTEMBER 14, 2023

Summary Transcript Summary Hospitals are hazardous places for older adults. These hazards include delirium, malnutrition, falls, infections, and hospital associated disability (which about ⅓ of older adults get during a hospital stay). What if, for at least some older adults who need acute-level care, instead of treating them in the hospital, we treat them at home?

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