June, 2024

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Dr. Logan Gladney: Heart Health Risk Assessment

Boulder Medical Center

What is your risk of having a major cardiovascular event such as a heart attack or stroke? Internist Logan Gladney, MD, shares tools that are used to assess heart disease. The post Dr. Logan Gladney: Heart Health Risk Assessment appeared first on Boulder Medical Center.

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Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

Summary Transcript Summary I have to start with the song. On our last podcast about urinary incontinence the song request was, “Let it go.” This time around several suggestions were raised. Eric suggested, “Even Flow,” by Pearl Jam. Someone else suggested, “Under Pressure,” but we’ve done it already. We settled on, “Oops…I did it again,” by Britney Spears.

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Getting Answers: A Patient's Guide to Discussing Unexplained Symptoms with Your Doctor

Vida Family Medicine

One of the most rewarding parts of being a primary care physician is when I am able to work with a patient to help them find answers to unexplained symptoms they have been dealing with, sometimes for years! Often patients tell me that they have struggled to find a doctor to help them or that previous doctors have dismissed or minimized their symptoms, or have not recommended any additional work-up after initial test results were normal.

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Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents

FDA Law Blog

By Sara W. Koblitz — As we have noted for the last year or so, the FTC has been on a mission to clean up the Orange Book by removing what it deems to be “improper” patents. The FTC has put out policy statements, challenged patent listings, tapped Congress, appeared on talk shows, and filed amicus briefs all in the span of the last 8 months. It seems like all that work is paying off.

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Episode 341: WDx #30: Introspective Spaces

The Clinical Problem Solvers

[link] Sharmin, Kaylin, and Jane interview Anu Gorukanti, MD and Laura Holford, RN MSN, the co-founders of Introspective Spaces. They discuss their journeys in healthcare and what motivated them to build an inclusive space to foster connection, cultivate contemplative practice, and empower women in healthcare through introspective and reflection. Anu Gorukanti, MD is a public health advocate and pediatric hospitalist at a county hospital in Los Angeles, CA who is passionate about health equity a

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The US Healthcare System vs…….South Park ?!?!

Noreta Family Medicine

The US Healthcare System vs…….South Park ?!?! I have to admit that I’ve never watched an episode of South Park. However, this clip was sent to me by another Direct Primary Care (DPC) doctor, and I thought that it was well done and that it deserved to be shared! Although the medical focus of this video is obesity, I was intrigued by the other highlighted theme – the endless spool of red tape in healthcare.

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Logansport Memorial Welcomes New Primary Care Physician

Logansport Memorial Hospital

Logansport Memorial is pleased to welcome Samuel Anderson-Been, MD to the Logansport Memorial Physician Network. He is a primary care physician with a passion for providing full-spectrum primary care for his patients. Beginning in August, Dr. Anderson-Been will see patients in LMPN Family Medicine, located on the second floor of Medical Office Building West.

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Prolapse: A Common Problem

Evergreen Family Medicine

Written By: Mary Powell, MD/OB/GYN Pelvic organ prolapse is a common condition that affects many women. It is estimated 1 out of 4 women in their 40s have some degree of prolapse. The prevalence increases as women age so much; that more women in their 80s have prolapse than do not. Prolapse literally means “to drop”. The pelvic organs (bladder, uterus with cervix, or bowel) can fall or drop out of their normal anatomical position.

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OTC Hearing Aids: “Nothing to See Here” Says GAO Report

FDA Law Blog

By Sara W. Koblitz & Jeffrey N. Gibbs — It’s been over a year and a half since Over-the-Counter (“OTC”) hearing aids became legal, and it’s not clear that they’ve made the difference in hearing loss treatment that Congress anticipated. (FDA once estimated that OTC hearing aids would save patients over $3000.) A recent GAO Report hasn’t found that OTC hearing aids have had much impact.

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Episode 339: Neurology VMR – left facial numbness for 5 days

The Clinical Problem Solvers

[link] Episode 339: Neurology VMR – left facial numbness for 5 days We continue our campaign to #EndNeurophobia, with the help of Dr. Aaron Berkowitz. This time, Aye presents a case of left facial numbness for 5 days to Andrea and Sridhara. Neurology DDx Schema Aye Chan Moe Thant Aye graduated from University of Medicine, Mandalay, Myanmar, and has been working with her mentor neurologist, one of only three neurologists covering the Upper Myanmar region of 23 million population.

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Medical Music Mondays: No X-Ray Today (Bronchiolitis!)

PEMBlog

It’s a new wave of information! RSV causes bronchiolitis. OK, so it’s not new. We can make a clinical diagnosis, and X-Rays are not necessary for most children with Bronchiolitis. Lyrics Wheezing and coughing subcostal retractions Nasal secretions suctioning action RSV causes the typical cases Worried looks on parental faces Usual course with typical findings Normal oxygen sats is a silver lining It’s bronchiolitis, diagnosis so easy There’s no need for X-Rays in a baby this wheezy H

Medical 52
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Anxiety in Late Life and Serious Illness: A Podcast with Alex Gamble and Brianna Williamson

GeriPal

Summary Transcript Summary “Anxiety is a lot like a toddler. It never stops talking, tells you you’re wrong about everything, and wakes you up at 3 a.m.” I’m not sure who wrote this quote, but it feels right to me. We’ve all had anxiety, and probably all recognize that anxiety can be a force of action or growth but can also spiral to quickly take over our lives and our sleep.

Illness 129
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Shoreham Bank Physician Mortgage Review (Updated 2025)

LeverageRx

BMO Harris Bank offers physician mortgage loans for medical professionals. Click to find out more about the details and benefits.

Medical 52
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2024 Summer Pinecones E-Newsletter -- ADVOCACY News

Maine Academy of Family Physicians

Here in Maine the "shorter" Legislative Session was quite full! Pat Connolly reported on the 2024 Maine Legislative Session: It was a short but busy session in Augusta this year. It began with a huge push for gun safety measures in the aftermath of the Lewiston Massacre. On the first day of the Legislature the State House was packed with people, myself included, brandishing orange ribbons in support of common-sense gun safety measures.

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Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections

FDA Law Blog

By Sarah Wicks & Anne K. Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program.

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Episode 340: Rafael Medina Subspecialty Series – Headache & Blurry vision

The Clinical Problem Solvers

[link] In this Nephrology Rafael Medina Subspecialty episode, Dr. Maddie Abrams presents a case to Dr. Jai Radhakrishnan of a 28 year old woman presenting with headache and blurry vision. 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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Medical Music Mondays: Something’s BRUE-ing Here

PEMBlog

It used to be ALTE but now it’s BRUE. Brief Resolved Unexplained Event. It is a better name after all. And it makes for better puns. Lyrics Sudden brief resolved single episode baby’s under a year old Cyanosis pallor or breathing and tone change altered responsiveness and no way to explain[chorus] something’s brewing here Brief resolved unexplained event observation’s warranted for high risk infants How these videos were produced This song and video were created using Art

Medical 52
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Cachexia and Anorexia in Serious Illness: A Podcast with Eduardo Bruera

GeriPal

Summary Transcript Summary I always find cachexia in serious illness puzzling. I feel like I recognize it when I see it, but I struggle to give a clear definition or provide effective ways to address it. In today’s podcast, we had the opportunity to learn from a renowned expert in palliative care, Eduardo Bruera, about cachexia and anorexia in serious illness.

Illness 133
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Shoreham Bank Physician Mortgage Review (Updated 2024)

LeverageRx

BMO Harris Bank offers physician mortgage loans for medical professionals. Click to find out more about the details and benefits.

Medical 52
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PreSTAR: a New Template for Pre Submissions and 513(g) Requests for Information

FDA Law Blog

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. A pre-submission provides the submitter an opportunity to obtain FDA feedback prior to a planned medical device premarket submission.

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OPQ’s State of Pharmaceutical Quality Report Is a Data Bonanza (with Cameos by Eye Drops and Hand Sanitizers)

FDA Law Blog

By Kalie E. Richardson & John W.M. Claud — FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) is charged with assuring that drugs marketed in the U.S. are safe, effective, and meet appropriate quality standards. While no office at FDA truly works in a vacuum, we can safely call OPQ the tip of FDA’s quality spear.

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HP&M Seeks Attorney with Significant Experience in Government Discount Programs and Price Reporting

FDA Law Blog

Hyman, Phelps & McNamara, P.C. (HP&M) seeks to add an experienced attorney (7+ years) to our government discount program and price reporting practice. Our ideal candidate will have significant substantive experience working with: Price calculation and reporting under the Medicaid Drug Rebate Program and the 340B Drug Discount Program Average sales price reporting under Medicare Part B Price reporting and contracting with the Department of Veterans Affairs Drug discounting requirements un

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HP&M’s Larry Houck A Panelist in FDLI’s Marijuana Rescheduling Webinar

FDA Law Blog

Last month the Department of Justice and the Drug Enforcement Administration submitted a notice of proposed rulemaking to reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. Hyman, Phelps & McNamara, P.C. Director Larry Houck will participate as a panelist focusing on this timely topic in the Food and Drug Law Institute’s (“FDLI’s”) “High Time for a Change: Implications of DEA’s Proposed Marijuana Rescheduling” webinar June 12, 2024, 2:00

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Pharmacists in Florida (and Elsewhere): Waive Prescribing Red Flags at Your Peril

FDA Law Blog

By Larry K. Houck — We blogged in February 2022 about the Drug Enforcement Administration’s (“DEA’s”) revocation of Gulf Med Pharmacy’s registration after finding that it failed to exercise its corresponding responsibility by repeatedly filling controlled substance prescriptions that exhibited “obvious red flags of diversion without documenting the resolution of those red flags.

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The Interchangeables Are A-Changin’: New FDA Guidance Proposes Eliminating Switching Studies Requirements

FDA Law Blog

By Sara W. Koblitz — In a short but sweet Guidance issued last week, FDA proposed a dramatic change to the way it evaluates interchangeable biosimilars. For the last 14 years, an applicant could get approval of a biosimilar as a standard biosimilar or an interchangeable biosimilar, but the interchangeable biosimilar presented a higher hurdle to approval: Applicants needed to show that a patient could be switched from the Reference Product to the biosimilar and back without issue.

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HPM Director Dara Katcher Levy to Present Webinar on AMCP Format for Formulary Submissions v5.0

FDA Law Blog

This afternoon Hyman, Phelps & McNamara, P.C. (HPM) Director Dara Katcher Levy will present an informative webinar on the newly released AMCP Format for Formulary Submissions version 5.0. The event, titled “New and Improved – AMCP Format for Formulary Submissions v5.0,” aims to educate pharmaceutical manufacturers and other healthcare stakeholders on the latest updates and best practices in dossier development.

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Medical Music Mondays: Turn the Heart Rate Down

PEMBlog

Supraventricular tachycardia is really fun to convert. You go do all kinds of vagal maneuvers which are basically heart games. Then there’s the REVERT maneuver – it works great! Search for it and learn it. Or watch this video. Lyrics S V T! A heart rate so fast as fast as can be S V T! EKG super fast rate with no p waves Q R S is narrow, that’s what you will see S V T!

Medical 52
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The OIG Don’t Like That: Rockin’ The Casbah, Rockin’ the Casbah

FDA Law Blog

By Jeffrey N. Wasserstein — Today’s email brings an interesting, and somewhat confusing settlement of what should have been an ordinary antikickback statute case , and may bring about a clash between what many companies do and what the government may be objecting to. Or, perhaps your loyal blogger is reading too much into a brief settlement document.

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Medical Music Mondays: Batteries Down the Hatch

PEMBlog

Swallowing button batteries is a dumb idea. It can melt your esophagus and stuff. Endoscopy is the way to remove them. But if you have a long delay there are sucralfate protocols. But just don’t swallow them in the first place. Lyrics If a button battery is swallowed please do not delay The electric charge can melt the mucosal wall all away If it’s stuck in the esophagus and you’ve got a real long wait You can give some temporizing enteral sucralfate But ultimately that kid nee

Medical 52
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Episode 338 – RLR – Brain Mass

The Clinical Problem Solvers

[link] Title – A Brain Mass Episode description Reza, Aaron and Rabih discuss a case of a patient with a brain mass Student discount [link] IMG discount Use coupon code RLRIMG at check out [link]

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Podcast: Cervical Spine Injuries & Imaging in Children

PEMBlog

Cervical Spine Injuries are fortunately rare in children. this episode is all about learning when to suspect them, how to immobilize the C-spine properly, and which imaging test to choose. It was inspired by a hot-off-the-presses publication from the Pediatric Emergency Care Applied Research Network (PECARN) focused on clinical decision rules for cervical spine imaging in children.

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More Diversion Cases and WCF’s Opioid & Fentanyl Abuse Management Summit

FDA Law Blog

By Larry K. Houck — It seems as though we cannot get through a week without hearing about controlled substance diversion by employees at another hospital or healthcare facility. We learned this week that Palomar Health, one of California’s largest healthcare districts, agreed to pay $250,000 to resolve allegations that numerous vials of fentanyl had been diverted from automated medication dispensing machines over a five-month period and that the hospital did not properly dispose of unused fentan

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RAPS Convergence 2024 to Feature Session on Accelerating Breakthrough Device Commercialization — Led by HPM Medical Device Regulatory Expert Adrienne Lenz

FDA Law Blog

RAPS Convergence 2024 is set to host a must-attend session on CDRH’s Total Product Life Cycle Advisory Program (TAP), promising attendees an exclusive insight into a pioneering initiative aimed at improving the medical device commercialization landscape. Session Details: A Path to Faster Breakthrough Device Commercialization – CDRH’s Total Product Life Cycle Advisory Program (TAP) Thursday, September 19, 2024, 4:30 PM – 5:30 PM Session Leader: Adrienne Lenz, RAC – Principal Medical Device Regula

Medical 52
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Ready, Set, START – 7 Programs Selected for FDA’s START Rare Disease Pilot Program

FDA Law Blog

By Sarah Wicks & Charles D. Snow & James E. Valentine & Frank J. Sasinowski — Hyman, Phelps & McNamara (HPM) would like to congratulate the 7 rare disease programs selected for the inaugural class of the FDA’s “Support for clinical Trials Advancing Rare disease Treatment” (START) pilot program. The START pilot program was announced last September as a way to offer selected participants developing potentially life-saving and life-changing rare disease therapies enhanced communicat

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Sexual Function in Serious Illness: Areej El-Jawahri, Sharon Bober, and Don Dizon

GeriPal

Summary Transcript Summary As Eric notes at the end of today’s podcast, we talk about many difficult issues with our patients. How long they might have to live. Their declining cognitive abilities. What makes their lives meaningful, brings them joy, a sense of purpose. But one issue we’re not as good at discussing with our patients is sexual health.

Illness 130
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Women’s Health a Focus for FDA and Biden Administration

FDA Law Blog

By Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA’s Office of Women’s Health (OWH) recently celebrated its 30th anniversary. This office was formed in 1994 to promote the inclusion of women in clinical trials and to provide leadership on topics related to the health of women. Given that FDA was founded in 1906 and the Federal Food, Drug and Cosmetic Act went into effect in 1938, the OWH’s thirty years of existence, while an important milestone, constitutes a very small amou

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DEA’s Expected Guidance: It Should Reduce Current “Pain” at the (Intrathecal Pain) Pump Dispensing Process and Improve Therapeutic Outcomes

FDA Law Blog

By John A. Gilbert & Karla L. Palmer — For more than 50 years, the Drug Enforcement Administration (DEA) has enforced the central mandate of the Controlled Substances Act (CSA) to maintain a closed chain of distribution for drugs with a potential for abuse and diversion. The CSA and regulations promulgated by DEA are intended to reduce the potential for diversion and abuse and ensure that controlled substances are dispensed and delivered to patients for a legitimate medical purpose.

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