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Aspiring Minority Doctor
DECEMBER 17, 2023
Okay, now I'll admit I've done a horrible job of keeping up with the blog lately especially given that this is only my fifth post of the year, but today is still super special for me. This blog has helped a lot with some of my successes. When I started this blog she had just turned 7, and now my baby is 17!
Integrated Care News by CFHA
MAY 8, 2025
WHO grouped these determinants into contextual, individual, and group influences and vaccine/vaccination-specific issues. I discussed this debate in my previous blog post. Addressing vaccine hesitancy requires tailored, evidence-based strategies to address the causes.
130 This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Common Sense Family Doctor
FEBRUARY 28, 2025
Family physicians are being squeezed by two accelerating trends: (1) too few of us to care for the growing US population and (2) the rising number of tasks that we are asked to accomplish for each patient. hours per day, with more than one-half of that time (14.1 hours) allocated to preventive care. hours) allocated to preventive care.
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FDA Law Blog
JULY 17, 2024
Peter Marks at James Valentine ’s FDA Rare Disease Town Hall session at the DIA Annual Meeting last month (see Pink Sheet coverage here ), this Hub is intended to serve as the Center of Excellence that we in the rare disease community have been calling for its establishment over the last several years.
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FDA Law Blog
DECEMBER 4, 2023
Pharmacists’ Corresponding Responsibility A controlled substance prescription, to be valid, must be issued for “a legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” The government asserted additional allegations that are outside our scope. Complaint ¶ 57. (The
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Vascular Physician
OCTOBER 26, 2021
What is Hyperbaric Oxygen Therapy and How it Helps Heal Wounds Hyperbaric oxygen (HBO) therapy involves treating patients with 100% oxygen (O2) at elevated atmospheric pressures in a specially designed chamber. Most patients lie on their backs or sit up just slightly.
FDA Law Blog
JUNE 3, 2025
Houck We appreciate receiving feedback on our blog posts. tablets to patients over the course of many months. However, the 2022 Clinical Practice Guideline, which updated the CDCs 2016 Guideline, notes that its recommendations are voluntary and intended to be flexible to support, not supplant, individualized, patient-centered care.
ABIM
APRIL 24, 2025
Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. ABIM does not contact individual programs with a lower pass rate to initiate changes to the program.
Priority Physicians
JANUARY 27, 2025
Find a caring primary care doctor: As a direct primary care physician, I devote time to sit down with patients and learn about their lifestyles, hopes, desires, worries, and concerns. Many individuals, distracted by the mind’s chatter, don’t realize their level of anxiety. He completed his residency at St.
GeriPal
MARCH 14, 2024
This simple challenge was focused on putting ourselves in the shoes of our patients with dysphagia who are prescribed thickened liquids. We also talk about the importance of a proactive approach to involving speech-language pathologists in the care of individuals early on with neurodegenerative diseases like dementia and ALS.
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FDA Law Blog
OCTOBER 14, 2024
California Stem Cell Treatment Center, Inc., At the clinics, Defendants offer treatments that consist of extracting fat tissue from patients and, through a multi-step process, turning that tissue into a liquefied mixture of stem cells, other cells and cell debris known as Stromal Vascular Fraction (SVF). By Steven J.
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FDA Law Blog
JANUARY 6, 2022
Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. 220 and was described on HP&M’s blog here. EKRA is codified at 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 220(e)(2).
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Priority Physicians
FEBRUARY 3, 2025
Both THC and alcohol come with risks and perceived rewards, depending on the individual. An Individual Decision Besides considering THC’s illegal status in Indiana, the choice to use is an individual one. Joseph Regional Medical Center in South Bend, IN and has a passion for putting his patients first in his practice.
FDA Law Blog
DECEMBER 13, 2023
Janet Maynard, Director of this Office, highlighted in the press release that “[g]enetic metabolic diseases include very rare diseases that individually affect a limited number of patients. Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.”
FDA Law Blog
MARCH 7, 2024
The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. DMC charters have also grown longer and more detailed.
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FDA Law Blog
NOVEMBER 6, 2022
Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R. SCOTUS has until Dec.
FDA Law Blog
AUGUST 28, 2023
The draft guidance Digital Health Technologies for Remote Data Acquisition in Clinical Investigations (which we previously blogged on here ) includes information on selection, verification, validation, and usability of DHTs and was referenced frequently in responses to participant questions.
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FDA Law Blog
OCTOBER 9, 2023
We previously blogged about this lawsuit last year. The ACA sets an annual cap on the amount that insurers can require insured individuals to pay out of pocket for their medical expenses. Once an individual reaches this annual cap, the insurer is solely responsible for covering the individual’s remaining medical expenses that year.
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FDA Law Blog
FEBRUARY 28, 2022
Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).
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FDA Law Blog
JUNE 23, 2021
Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E. The practice of medicine was viewed as paternalistic.
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FDA Law Blog
JANUARY 6, 2022
Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. 220 and was described on HP&M’s blog here. EKRA is codified at 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 220(e)(2).
40 
FDA Law Blog
OCTOBER 12, 2022
Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient. syringes), to any individual without a patient-specific prescription. plies for administration (e.g.,
52 
FDA Law Blog
APRIL 23, 2023
Because an external control can involve the use of real-world data (“RWD”), the Draft Guidance notes that this guidance is being issued to satisfy, in part, requirements from the 21st Century Cures Act on the use of real-world evidence (“RWE”) in regulatory decision-making, similar to other recent efforts in this arena that we have blogged about.
FDA Law Blog
JANUARY 31, 2023
So when patients led by Abbey Meyer and Marjorie Guthrie (Woody Guthrie’s widow) had championed the 1983 law to create incentives for developing drugs for those with rare conditions, the FDA was excited at this once-in-a-generation new law as this was FDA’s 3ed major drug law in nearly half a century. Nancy Katzenbaum….patient
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FDA Law Blog
SEPTEMBER 20, 2021
From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.
FDA Law Blog
OCTOBER 11, 2022
Valentine — As we begin the final quarter of 2022 and the leaves here on the east coast begin to turn and fall, it seems the clock may be running out on FDA and the Center for Drug Evaluation and Research (CDER) to meet its goal of publishing a draft guidance on confirmatory evidence this year. Sasinowski & James E.
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FDA Law Blog
NOVEMBER 1, 2023
The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software. FDA’s position is, however, only one side of the story.
FDA Law Blog
JANUARY 26, 2022
By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! In defending the complete broadcast, Lilly called out similar elements from each of the individual components as demonstrating its intent to have all three viewed sequentially.
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PEMBlog
OCTOBER 2, 2024
I’ll make the important distinction between gastritis – which is diagnosed only via endoscopy – and dyspepsia, the term best used to describe the symptoms many patients experience. Gastroesophageal reflux disease is when the patients have severe symptoms that persist and cause long term issues.
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FDA Law Blog
MARCH 17, 2022
Houck — The Centers for Disease Control and Prevention (“CDC”) issued a voluntary practice guideline on opioid prescribing for clinicians treating chronic pain five years ago. (We We blogged on the final 2016 guideline here on March 17, 2016). By Larry K. Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids, 87 Fed.
Rao Doctor
APRIL 3, 2025
Rectal method is more appropriate for infants, children and unconscious or comatose patients who are not able to hold the thermometer in their mouth. The choice of method depends on the patient’s age, condition, and preference, with rectal measurements often being the most precise for infants and young children.
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GeriPal
FEBRUARY 29, 2024
Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
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GeriPal
JANUARY 18, 2024
We start off the conversation by talking about whether patients with cancer and cancer pain are really that different, and their paper that was just published on January 11 th in JAMA Oncology showing that substance use disorder is not uncommon in individuals with cancer. Katie, welcome back to GeriPal. What is it called?
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GeriPal
DECEMBER 8, 2022
Clinicians “catching” patient life stories. . Our patients aren’t “the 76 year old with heart failure in room 202,” as Heather Coats astutely noted. Storytelling Helps Hospital Staff Discover The Person Within The Patient. A few data based publication links from Person-Centered Narrative Intervention Program of Research: .
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ABIM
JUNE 11, 2025
Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. The following is a summary of the spring meeting. Society guests departed at this point in the meeting.
FDA Law Blog
NOVEMBER 29, 2022
CDC received some 5,500 comments from patients, caregivers, clinicians and interested organizations to the proposed guideline update it issued in February. We blogged on the 2016 guideline here in March 2016, and the proposed guideline here on March 18th). MMWR Recomm Rep 2022;71(No. RR-3):1–95. 2022 Guideline”). DOI: [link].
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The Clinical Problem Solvers
MAY 30, 2022
This discussion is hosted by Naomi Fields, MD, Chioma Onuoha, and Victor Lopez-Carmen MPH, as they interview Dr. Kozhimannil—the Distinguished McKnight University Professor in the Division of Health Policy and Management at the University of Minnesota and Director of the Rural Health Research Center.
52 ABIM
JUNE 24, 2025
Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Learn More Subscribe to the ABIM Blog to stay on top of the latest news. The following is a summary of the spring meeting.
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