Minnesota Academy of Family Physicians

FEBRUARY 20, 2025

Streamline Referrals: Utilize technology like the Hunger Vital Signs tool and the Minnesota Food Helpline to connect patients directly to mobile food units, emergency food programs or Supplemental Nutrition Assistance Program (SNAP) enrollment services. Park Nicollet Health Services combines nutrition education with SNAP referrals.

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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 ). Valentine & Larry J.

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FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.” By Jeffrey N. percent of examples.

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FDA Law Blog

SEPTEMBER 11, 2023

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510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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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.

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FDA Law Blog

JUNE 21, 2023

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. At-home medical technologies include, but are not limited to, monitoring and wearable devices (e.g.,

Medical 45

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FDA Law Blog

NOVEMBER 6, 2023

Admittedly, BiMo inspections (into items like adequacy of bioequivalence data, consistency of clinical trial data with medical records, and compliance with clinical trial protocols) lend themselves better to an RIE than assessing manufacturing compliance with regulatory requirements. We should explain what RIEs are.

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FDA Law Blog

AUGUST 4, 2022

In September 2020, the Agency issued an unfavorable advisory opinion to Pfizer, concluding that the proposal was “highly suspect” under the AKS “because one purpose of the [proposed program]—perhaps the primary purpose—would be to induce Medicare beneficiaries to purchase [Pfizer’s] federally reimbursable Medications.”

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FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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FDA Law Blog

AUGUST 23, 2023

DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites. In March of this year, FDA convened the first public meeting, Understanding Priorities for the Use of Digital Health Technologies to Support Clinical Trials for Drug Development and Review.

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FDA Law Blog

DECEMBER 12, 2023

In fact, clinical studies estimate that as many as 23% of cats suffer from urolithiasis. RSS is a measurement used to estimate the potential for crystal formation and bladder stone (urolith) growth, a common affliction in cats.

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FDA Law Blog

APRIL 30, 2024

Baumhardt, Senior Medical Device Regulation Expert — FDA recently issued a draft guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program , which included some changes over the existing guidance which could have a negative impact on future pre-submissions.

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FDA Law Blog

DECEMBER 16, 2024

Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. By Adrienne R.

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PEMBlog

AUGUST 30, 2023

This is a blog post and a podcast episode 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.

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Physician's Practice

JUNE 25, 2025

Reynolds Blog Video Neil Baum, MD, asks whether your patients are satisfied with their care and shows how a quick survey could make the difference. Dr. Baum is Professor of Clinical Urology at Tulane Medical School in New Orleans, Louisiana. Dr. Baum was the columnist for American Medical News for more than 25 years.

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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. JAMA Pediatr. Hosp Pediatr.

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GeriPal

MARCH 14, 2024

Eric: Well, before we talk about dysphagia and revisit it, which is also interesting, because this is our first podcast, I think on dysphagia, but we’ve talked about it before on GeriPal, in our blog. Nicole: Yeah, I think definitely delirium, but there are also a lot of medical conditions that can be specific to hospitalizations.

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FDA Law Blog

JUNE 27, 2024

paid for some medications with insurance while paying for other controlled medications in cash, and Patient M.W. A pharmacist is prohibited “from filling a prescription for a controlled substance when he either knows or has reason to know that the prescription was not written for a legitimate medical purpose.” By Larry K.

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Physician's Practice

JUNE 27, 2025

Reynolds Blog Article The small details, like restroom cleanliness, shape patient perceptions and impact healthcare experiences in practices. I refer to this thought transference as the Bathroom Experience (BE), a powerful metaphor for how seemingly minor details can dramatically impact patients’ perceptions of a medical practice.

Management 52

Management Private Practice Patients Medical 52

Physician's Practice

JUNE 24, 2025

Reynolds Fact checked by Chris Mazzolini Blog Article Thoughtful design in medical practices enhance patient experience, boost staff productivity, and improve online reviews without major renovations. First impressions in medicine form long before anyone touches a stethoscope.

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Physician's Practice

JUNE 9, 2025

Reynolds Blog Article Physicians Practice Physicians Practice June 2025 Volume 3 Issue 3 Physicians navigate challenging payer negotiations, sharing success stories of securing approvals for innovative, cost-effective treatments. is a professor of clinical urology at Tulane University in New Orleans, Louisiana. Neil Baum, M.D. ,

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Management Healthcare Experience Patients Hospital 52

FDA Law Blog

OCTOBER 14, 2021

Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes. It is well out of bounds for FDA to regulate them as if they were a determinant of long term clinical outcomes. Gone are the days of tool type indications for this type of device. 21 U.S.C. §

Patient-Centered 52

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FDA Law Blog

APRIL 23, 2023

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. Outcomes of interest are more likely to be recorded in clinical records when the events are objective and require immediate medical attention (e.g., stroke).

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Physician's Practice

JUNE 20, 2025

Reynolds Blog Article Innovative medical practices thrive by embracing change, prioritizing patient care and learning from setbacks to enhance success and satisfaction. This blog will discuss what early adopters do to implement innovative and exciting practices.

Management 52

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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. Glucose We all need it.

Patients 52

Patients Screening Illness Physicals 52

FDA Law Blog

SEPTEMBER 20, 2021

Some of these will be subjects of more detailed posts in the future and readers should keep an eye on the blog for additional coverage. STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs.

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FDA Law Blog

DECEMBER 11, 2023

6] It is inconsistent to say that LDTs must be regulated as medical devices because of the newness of the tests and then reduce the cost of the proposed regulation by declaring that half of all LDTs will be exempt from premarket review. FDA, Performance Report to Congress: Medical Device User Fee Amendments FY 2022, at 13-18, [link]. [14]

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FDA Law Blog

AUGUST 3, 2022

3, 1992) (“It has come to the attention of FDA that laboratories have been manufacturing, “home brew” products, either from products already on the market, or from components, and utilizing these unapproved products for diagnostic purposes. These products are subject to the same regulatory requirements as any unapproved medical device”).

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FDA Law Blog

JUNE 7, 2021

However, the FDA guidance goes on to say in some cases, additional context is needed by specifically inserting a sentence in the indications statement that: no clinical benefit has been established. be “reasonably likely to predict” ultimate clinical benefit).

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GeriPal

APRIL 14, 2022

So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. This is both a research and a clinical interest of yours. They don’t have an addiction clinic. Eric: And why Under Pressure. I’m going to start off with Katie. Right, Katie?

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FDA Law Blog

JULY 9, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. We’ve blogged about some of FDA’s efforts to increase diversity in clinical trials previously, and the Draft Guidance itself describes a variety of these efforts. 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)).

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FDA Law Blog

FEBRUARY 22, 2022

Additionally, the NIH assists with all the analytical and clinical testing, using protocols already vetted with FDA. This testing is done by testing labs and clinical research organizations (CROs). To our knowledge, five clinical studies conducted by NIH have failed to hit 80% sensitivity.

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PEMBlog

MARCH 27, 2024

She did her MD/PhD at Columbia University, where she investigated the diagnostic utility of exome sequencing for kidney disease. Brad’s not a pediatric medical geneticist. So my special guest host on this episode is a trainee in pediatrics and medical genetics. On clinical presentation. No, I’m not.

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FDA Law Blog

JANUARY 4, 2023

Prescription drug and medical device Pre-Approval Information Exchange (PIE) now has specific legal protection allowing for sponsors to proactively communicate to payors certain information about products in development to help expedite patient access upon product approval. By Dara Katcher Levy — A win for patient access!

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Patients Provider IT Utilities 64

GeriPal

DECEMBER 19, 2024

They are recruiting for a Medical Director of Palliative Care Services to lead and grow innovative outpatient and inpatient palliative care programs. That’s how do we treat the mental health needs of patients with serious medical illness? Again, what we should focus on is improving your quality of life and maybe non medical ways.

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Illness Mental Health IT Patient-Centered 101

FDA Law Blog

JUNE 2, 2023

For 10 high-cost single source covered outpatient drugs selected annually by CMS, manufacturers would be required to respond to a so-called “price verification survey” by providing not only clinical and utilization information about the drug, but also costs of production, distribution, research, and marketing; revenue and profit; and ex-U.S.

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PEMBlog

APRIL 26, 2023

I’m Dr. Carney and I am a pediatric resident at Cincinnati Children’s Hospital Medical Center. Today, we are going to discuss firearm safety and ways to screen for it in both the ED and clinic settings. Retrieved October 7, 2022, from [link] Episode Transcript [Kit] Hello! I’m here with my co-resident, Dr. Humphrey.

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