The Clinical Problem Solvers

OCTOBER 23, 2019

The “Clinical Reasoning Corner” will provide an introduction to the topics that keep our reasoning rooted in the core principles of clinical problem solving. Pre and posttest probabilities provide a framework that helps us decide which diagnostic tests to send, interpret their results, and prioritize our differential. Let’s dive in!

Clinic 52

Clinic Diagnosis Diagnose Utilities 52

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The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post.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the use of DMCs (or DSMBs, DSMCs, IDMCs) should carefully consider the recommendations and advice provided in this draft guidance, even prior to its finalization.

Clinic 105

Clinic Provider IT Utilities 105

Physician's Practice

JUNE 25, 2025

Topics Access and Reimbursement Billing & Collections Coding & Documentation Finance Law & Malpractice MedMal by Coverys Patient Engagement & Communications Staffing & Salary Technology Media Video & Interviews Podcasts Medical World News Pearls Surveys Best States to Practice Great American Physician Survey Staff Salary Survey (..)

Patients 52

Patients Private Practice Management Healthcare 52

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.

Diagnosis 122

Diagnosis Diagnose Hospital Clinic 122

Vascular Physician

DECEMBER 2, 2020

While bypass surgery is a "real" operation, in many cases it can solve the patients problem for many years or forever, compared to angioplasty and stenting which may need to be repeated frequently to keep the blood flow open. Patients with peripheral artery disease often have a history of limb claudication, which refers to pain with exertion.

Medical Student 52

Medical Student Complication Hypertension Utilities 52

FDA Law Blog

MAY 13, 2024

FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices. Rather than looking at how RWD/RWE provide meaningful information on safety and effectiveness, reviewers often focus on perceived gaps.

Medical 111

Medical Clinic Patients IT 111

FDA Law Blog

SEPTEMBER 11, 2023

This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway. In a statement released at the time, CDRH Director Jeffrey Shuren, M.D.,

Medical 64

Medical Electronics Manufacturing Utilities 64

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 ).

Patients 52

Patients Clinic Medical Patient-Centered 52

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.

Lab Testing 52

Lab Testing Medical Patients Mental Health 52

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.

Patients 52

Patients Illness Hospital Management 52

Vascular Physician

FEBRUARY 23, 2020

Ultrasound and CTA can also be utilized to evaluate blood flow through vessels and narrowing of arteries. Patients usually complain of worsening pain at night that is only relieved by hanging the affected leg over the side of the bed or with ambulation.

Referral 40

Referral Hypertension Primary Care Utilities 40

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. Pfizer’s Petition to SCOTUS.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law Blog

JUNE 21, 2023

According to the announcement, enabling patients to access medical devices beyond traditional clinical settings can help close the healthcare gap by delivering care “directly to patients, wherever they are – at home, at work, in cities, in rural communities.” and remote or wearable patient monitoring devices (e.g.,

Medical 45

Medical Patients Healthcare Electronics 45

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.

Patient-Centered 52

Patient-Centered Clinic Medical Utilities 52

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.

Asthma 52

Asthma Electronics Utilities Clinical Practice 52

FDA Law Blog

JUNE 27, 2024

Prescribing Red Flags In the Gulf Med decision, DEA emphasized that “[r]ed flags are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm.” The expert specifically found that: Patient A.R. By Larry K. Gulf Med Pharmacy; Decision and Order, 86 Fed.

Insurance 52

Insurance Patients Utilities Chronic Condition 52

FDA Law Blog

JULY 17, 2022

Kirschenbaum — Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package. million).

Manufacturing 52

Manufacturing Utilities Government Provider 52

Physician's Practice

JUNE 27, 2025

Topics Access and Reimbursement Billing & Collections Coding & Documentation Finance Law & Malpractice MedMal by Coverys Patient Engagement & Communications Staffing & Salary Technology Media Video & Interviews Podcasts Medical World News Pearls Surveys Best States to Practice Great American Physician Survey Staff Salary Survey (..)

Management 52

Management Private Practice Patients Medical 52

FDA Law Blog

OCTOBER 14, 2021

Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. 21 U.S.C. §

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

FDA Law Blog

DECEMBER 6, 2024

This could occur during an End-of-Phase 2 (EOP2) meeting if a Phase 2 study is expected to provide primary evidence of safety and effectiveness. For cell therapy products, the draft guidance notes that in vivo imaging techniques provide certain advantages.

Clinic 59

Clinic Provider IT Electronics 59

Physician's Practice

JUNE 20, 2025

Topics Access and Reimbursement Billing & Collections Coding & Documentation Finance Law & Malpractice MedMal by Coverys Patient Engagement & Communications Staffing & Salary Technology Media Video & Interviews Podcasts Medical World News Pearls Surveys Best States to Practice Great American Physician Survey Staff Salary Survey (..)

Management 52

Management Patient-Centered Appointment Patients 52

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. The goal is to select similar patients in the treatment and external control groups. The Draft Guidance also states that sponsors must include in their marketing applications relevant patient-level data for both arms.

Patient-Centered 49

Patient-Centered Clinic Patients Provider 49

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.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 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

FDA Law Blog

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. Lax Controls Provided Employees with Opportunity to Divert. In short, the employees were provided the opportunity to not only commit the crimes but that they went undetected.

Board-Certified 52

Board-Certified Provider Government Management 52

FDA Law Blog

JUNE 16, 2023

The statement must itemize the cost components related to production of the drug, identify increases in materials or manufacturing costs, and provide other information that the manufacturer believes relevant to determining whether a violation has occurred. SF 2744 also provides a private right of action to enforce the prohibition.

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law Blog

DECEMBER 11, 2023

Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations. 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.

IT 69

IT Medical Patient-Centered Provider 69

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! With apologies to Rob Base and DJ EZ Rock , it took more than “two” to get this Emgality DTC TV commercial right (insert snare drum here please).

IT 40

IT Education Utilities Patient-Centered 40

FDA Law Blog

MARCH 20, 2022

The Guidance provides detail on a recalling firm’s responsibilities, preparations, and communications and how the Agency can assist a firm with carrying out its recall responsibilities. The Guidance provides practical guidelines for both firms and direct accounts. The Guidance emphasizes that firms need to be “recall ready.”

Electronics 40

Electronics Manufacturing Provider IT 40

FDA Law Blog

JULY 13, 2022

Without any predictability or clarity, biosimilar manufacturers will be less likely to take on the risk of developing these critical medicines, and patients will ultimately have less options. Moreover, there are some significant limitations to the application of this delay provision that appear to make it difficult to utilize.

IT 52

IT Manufacturing Utilities Complication 52

PEMBlog

MAY 15, 2023

Our role as providers is to identify the patients who have a life-threatening etiology to their syncope. History and physical examination are critical components to any emergency department evaluation but are especially helpful in syncope patients. 2020, pemcincinnati.com/blog/redflags-syncope/. 2017): 189-198.

Utilities 97

Utilities Screening Physicals Medical 97

FDA Law Blog

JANUARY 4, 2023

By Dara Katcher Levy — A win for patient access! 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.

Patients 64

Patients Provider IT Utilities 64

New South Family Medicine and MedSpa

NOVEMBER 24, 2022

Direct primary care offers you and your family top-notch health care, and so much more.like a high patient and provider satisfaction with an improved quality of care. Instead, they establish a direct patient-provider relationship, for a flat fee. DPC offers several in-house services like.

Family Medicine 40

Family Medicine DO Family Families 40

GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . 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. Learn about using the low dose buprenorphine patch: . Give some pleasure.

Illness 102

Illness Patient-Centered IT Patients 102

FDA Law Blog

OCTOBER 28, 2021

In some instances, however, this is only the first hurdle to make innovative products available to patients. In 2010, the Patient Protection and Affordable Care Act (ACA) established a mandate requiring coverage for women’s preventive services including contraceptives. 300gg-13(a)(4).

Insurance 40

Insurance Utilities Individual Provider 40

FDA Law Blog

FEBRUARY 22, 2022

We identified as the main culprit FDA’s requirement that these tests achieve 80% sensitivity (positive percent agreement or PPA) even when a required percentage of low positive patients are included. The NIH also only accepts manufacturers into the program if they can demonstrate the ability to provide high volumes (e.g.,

Manufacturing 52

Manufacturing Screening Provider Clinic 52

FDA Law Blog

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. pricing, among other things.

Manufacturing 59

Manufacturing Utilities Provider IT 59