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. Essentia Health partners with Second Harvest Northland to provide emergency food access.

Family Physician 52

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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. Many healthcare facilities in the U.S. Enter temporary medical staff, such as locum tenens providers.

Medical Staff 52

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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. 2017;186:87-94.e16.

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Physician's Practice

JUNE 26, 2025

Reynolds Fact checked by Chris Mazzolini Blog Article Telehealth has evolved into a vital service channel, yet many practices struggle with inadequate setups. Telehealth is no longer an emergency patch; it’s a front-door service channel that patients expect to work every bit as cleanly as a clinic visit.

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FDA Law Blog

SEPTEMBER 11, 2023

The electronic Submission Template and Resource (eSTAR) program, which we blogged about here and here , also makes the highlight reel given its aim to improve consistency and efficiency in how 510(k)s are prepared. Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway.

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FDA Law Blog

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). Throughout the SIUU Guidance, FDA refers to studies and analyses , suggesting that publications may cover more than a description of an adequate and well-controlled clinical trial.

Clinic 64

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FDA Law Blog

MAY 13, 2024

FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.” percent of examples.

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FDA Law Blog

FEBRUARY 28, 2022

address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”. What would be the potential benefits if companies prospectively design medical device clinical studies with input from diverse patient advisors?

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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.

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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. DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites.

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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

AUGUST 4, 2022

Further, “there is little utility in comparing the language of the BIS to that of the AKS.”. Pfizer emphasized to OIG that it would not offer this copay assistance as part of any advertisement or solicitation for tafamidis. The Lesson of this Case.

Manufacturing 98

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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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Asthma Electronics Utilities Clinical Practice 52

FDA Law Blog

DECEMBER 16, 2024

We previously discussed the Third Party Review Program in a blog post last year when FDA mentioned its expansion as part of its plan to address the resource gap for review of laboratory developed tests (LDTs) under the LDT final rule.

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FDA Law Blog

APRIL 30, 2024

This hardly provides clarification and seems to limit the topics that could utilize this method of feedback. For questions related to clinical study protocol, the draft guidance recommends that Sponsors provide the planned indications for use and describe the non-clinical data that will be included in a subsequent marketing application.

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Utilities Provider Medical IT 64

FDA Law Blog

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. Section #3: Human Trials Finally, the guidance provides a quick overview of clinical study recommendations.

Clinic 59

Clinic Provider IT Electronics 59

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.

Patients 52

Patients Illness Hospital Management 52

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. What medical technologies could be ideal to transition to use in non-clinical settings?

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FDA Law Blog

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.” 21 U.S.C. § 355(i)(1)(A). 42 U.S.C. §

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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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FDA Law Blog

JUNE 27, 2024

to promote therapeutic appropriateness by identifying: (a) Over-utilization or under-utilization; (b) Therapeutic duplication; (c) Drug-disease contraindications; (d) Drug-drug interactions; (e) Incorrect drug dosage or duration of drug treatment; (f) Drug-allergy interactions; [and] (g) Clinical abuse/misuse.” By Larry K.

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Insurance Patients Utilities Chronic Condition 52

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. I think someone has a song request for Alex. Raele: I do. I have one. Change by Blind Melon. Eric: Why did you choose this? Eric: Fancy.

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IT Hospital Patient-Centered Individual 124

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. Health Aff (Millwood).

Lab Testing 52

Lab Testing Medical Patients Mental Health 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

Patient-Centered Healthcare Manufacturing Provider 52

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. June 25, 2025 By Neil Baum, MD Fact checked by Keith A. About Neil Baum, M.D.

Patients 52

Patients Private Practice Management Healthcare 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.

Management 52

Management Patients Consulting Finance 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. The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

Physician's Practice

JUNE 27, 2025

Reynolds Blog Article The small details, like restroom cleanliness, shape patient perceptions and impact healthcare experiences in practices. This article inspired by Shep Hyken’s article appearing in Forbes Magazine Neil Baum, MD , a Professor of Clinical Urology at Tulane University in New Orleans, LA.

Management 52

Management Private Practice Patients Medical 52

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. ,

Management 52

Management Healthcare Experience Patients Hospital 52

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.

Patients 52

Patients Screening Illness Physicals 52

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

Management Patient-Centered Appointment Patients 52

FDA Law Blog

DECEMBER 11, 2023

14] Thus, while the Third-Party Review Program is not well‑utilized generally, it is not utilized at all by the in vitro diagnostic industry. Searches were done for all IVD panels: immunology, microbiology, clinical chemistry, pathology, toxicology, hematology, and molecular genetics. [15] of 510(k) decisions, respectively. [13]

IT 69

IT Medical Patient-Centered Provider 69

FDA Law Blog

JUNE 16, 2023

Identified drugs and related price information will be publicly disclosed, except for information the Board determines to be proprietary, not public, or trade secret. The Board may then initiate a cost review of any such identified drug product.

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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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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. As we began to prepare this blog, we thought it might be both birthday card and death notice for LDTs.

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Lab Testing Government IT Manufacturing 98

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?

Illness 102

Illness Patient-Centered IT Patients 102

FDA Law Blog

OCTOBER 16, 2024

Left ventricular ejection fraction (LVEF) is a variable measure, so use clinical judgment in deciding whom to treat.” The skinny label—whether utilizing omission or labeling modification—can continue to exist, allowing generic manufacturers to come to market earlier for non-protected uses of RLDs.

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