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The Health Policy Exchange
SEPTEMBER 2, 2020
Our residency, formerly a collaboration with Providence Hospital, is now known as the Medstar Health/Georgetown-Washington Hospital Center Family Medicine Residency Program. - Kenny Lin, MD, MPH Much has changed in the past six years since our last Health Policy Journal Club at Georgetown. I stepped down as director of the Robert L.
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Integrated Care News by CFHA
MAY 8, 2025
Evidence-based strategies for increasing vaccine uptake A recent systematic review provides an overview of evidence-based strategies for increasing vaccine uptake and indicates that multi-component interventions are more effective than single-component interventions. I discussed this debate in my previous blog post.
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Sound Physicians
JUNE 9, 2025
Family practitioners hold critical knowledge about that patient’s health history to help guide a more successful stay in the hospital. Finally, caregivers—often family members—play a critical role in educating the care team, flagging barriers to care once out of the hospital, and providing necessary insights into the bigger picture.
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Louisville Lectures
MAY 5, 2023
Boot Camp: PHASE TWO Or, Emergencies and Assessing Them This week, we will look at two highly anticipated videos, Electrolyte Emergencies by Dr. Eleanor Lederer and Assessing the Seriously Ill Patient by Dr. David Nunley. Are you a resident or medical student looking to learn practical, evidence based approaches to your patients?
Common Sense Family Doctor
JANUARY 19, 2025
Most patients who choose colonoscopy as a screening test for colorectal cancer are referred from primary care to a gastroenterologist or other specialist who performs endoscopy. But that wasn’t the case for the estimated 1 in 15 US patients whose screening colonoscopies were performed by family physicians in 2021.
Barton Associates
MAY 8, 2025
In this blog, we’re going to outline four key ways temporary medical staff such as locum tenens providers can help healthcare facilities maintain continuity of high-quality patient care in the face of growing shortages. Keep emergency departments and urgent care centers fully operational.
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
Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. Early Direction for the Rare Disease Innovation Hub The Hub, which will be co-chaired by Drs.
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Family Integrative Medicine
AUGUST 7, 2024
At Family Integrative Medicine, our commitment to personalized, patient-centered care is enhanced by the expertise and compassion of our dynamic team, including our exceptional female healthcare providers.
FDA Law Blog
OCTOBER 16, 2023
In particular, the article discusses FDA’s April 2023 draft guidance on pre-determined change control plans (which we previously blogged on here ) and whether such plans afford sufficient flexibility for AI/ML developers to innovate and improve products based on new data while also providing sufficient guardrails to ensure patient safety.
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Priority Physicians
JANUARY 20, 2025
But if you’re a patient of a direct primary care (DPC) practice , you don’t need to guess about orthopedic pain management. Unfortunately, traditional care doctors often resort to the two easiest options for patients with joint or back pain: They send the patient for imaging or refer them to a specialist.
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Logansport Memorial Hospital
APRIL 23, 2024
In this blog article, Dr. Scott Marsh, our podiatrist here at Logansport Memorial, shares some tips to keep your feet healthy. Wearing sandals around the pool is okay, but avoid wearing them daily as they do not provide adequate support for your feet. Consider trying a sandal with arch support.
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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. Sponsors considering the use of DMCs (or DSMBs, DSMCs, IDMCs) should carefully consider the recommendations and advice provided in this draft guidance, even prior to its finalization.
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FDA Law Blog
MAY 29, 2025
As we recently blogged about here and here , FDA has issued guidance on lifecycle management for AI-enabled device software functions. Therefore, it seems reasonable that AI models could be trained on the data, provide useful insights to reviewers, and speed up review times. We have all seen AI failures online, some amusing (e.g.,
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FDA Law Blog
OCTOBER 6, 2023
There is much to unpack, and we intend to do so in a series of blog posts. What, if any, unintended consequences may result from the proposed phaseout policy to certain patient populations (for example, Medicare beneficiaries, rural populations, etc.) Change to the IVD definition First, the mechanics of the change.
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FDA Law Blog
DECEMBER 4, 2023
Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. Providers should be aware of the other drugs prescribed to their patients. By Larry K. Complaint ¶ 57. (The
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FDA Law Blog
FEBRUARY 20, 2023
That’s a good list of the kinds of things that most consumers really do not want their digital medical services provider to do with their sensitive personal information. It permanently bans the company from trafficking-in patient data on several fronts. FDA is building its Digital Health Center of Excellence (DHCE).
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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. Representatives from the American College of Rheumatology (ACR) joined for a portion of the meeting*. McDonald affirmed as a long-term goal.
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. If anticipatory anxiety strikes — or, more importantly, persists — your Priority Physicians will provide guardrails to get you back to your best self.
FDA Law Blog
JULY 10, 2024
Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.
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PEMBlog
MAY 20, 2025
Learning Objectives Demonstrate the ability to use shared decision-making strategies when discussing imaging options with families of pediatric patients presenting to the Emergency Department. Optimizing Advanced Imaging of the Pediatric Patient in the Emergency Department: Policy Statement. Pediatrics. 2024;154(1):e2024066854.
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FDA Law Blog
AUGUST 23, 2023
This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.
FDA Law Blog
APRIL 13, 2025
By Sarah Wicks & Dara Katcher Levy FDAs Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter of 2025 to Taiho Oncology (Taiho) for a healthcare provider branded website for its drug LYTGOBI (futibatinib). Join us as we break down what went wrong this time. What Happened?
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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
JANUARY 12, 2025
Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. As such, we will publish a separate blog post focused on confirmatory trials and how FDA is interpreting this key provision of its accelerated approval authority.
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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
NOVEMBER 6, 2024
As the Court explains, an orphan drug may not be the “same drug” as the same active moiety under the Orphan Drug Act and FDA’s longstanding implementing regulations if one is “clinically superior” than the other by way of greater efficacy, greater safety, or major contribution to patient care (“MC-to-PC”).
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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
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
JUNE 2, 2022
This meeting brings together industry, regulators, academics, and patients to discuss global and local challenges in the life sciences industry. Patient-Focused Drug Development: Reflecting on a Decade of Insights (June 21, 11am-12pm Central). FDA Rare Disease Town Hall with CDER & CBER Center Directors (June 22, 2-3pm Central).
FDA Law Blog
JANUARY 5, 2023
Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. By John W.M.
FDA Law Blog
APRIL 6, 2025
Naomi Lowy joins HPM as a Principal Drug Regulatory Expert after 18 years at the FDAs Center for Drug Evaluation and Research (CDER), most recently as the Deputy Director, Division of General Endocrinology.
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Priority Physicians
FEBRUARY 3, 2025
Joseph Regional Medical Center in South Bend, IN and has a passion for putting his patients first in his practice. MORE BLOGS ← PREVIOUS NEXT → Learn more about membership with Priority Physicians For more details on our services and the concierge care we provide to our members, contact us today.
FDA Law Blog
OCTOBER 14, 2021
Mullen — In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. These clearances are based on short-term (30 day) patient follow up. By Jeffrey K. Shapiro & Allyson B.
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. § 18 U.S.C. §
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FDA Law Blog
OCTOBER 9, 2023
We previously blogged about this lawsuit last year. To help patients afford the copays and deductibles for specific medications, some drug manufacturers offer direct financial assistance, often as coupons, to subsidize the patient’s purchase of the drug at the point of sale.
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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
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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