Noreta Family Medicine

JANUARY 29, 2024

As a family doctor, I hear my patients talk about their “medicine cabinet full of old medicines” all the time. By reading this blog, I hope you will learn why it’s important to not only get rid of those old medicines but how to get rid of them properly. It’s ok to admit it. Why is it important to get rid of old medicines?

Primary Care Doctor 52

Primary Care Doctor Family Physician Primary Care Family 52

FDA Law Blog

OCTOBER 16, 2023

Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Javitt & Steven J. Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products.

Medical 119

Medical Patient-Centered Healthcare Specialization 119

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. It’s important to maintain the health of your feet because they can be a clue to your overall health. For example, numbness in your feet may be a sign of diabetes or swelling could indicate high blood pressure.

Appointment 52

Appointment Diabetes Patient-Centered Specialization 52

Vascular Physician

JANUARY 11, 2023

Anesthesia Before Vascular Surgery: Things to Know As with any surgery, a major consideration for patients is whether their bodies can handle anesthesia safely. Every surgical procedure a vascular surgeon performs requires a unique approach from anesthesia to help guide the patient through a safe and pain-free surgery.

Complication 52

Complication Patients Management Specialization 52

ABIM

JUNE 17, 2025

Reau, MD Dr. Reau is ABIM Board Certified in Gastroenterology and Transplant Hepatology, specializing in viral hepatitis. As internists, even if we subspecialize, we should be equipped to care for the full spectrum of issues our patients face, and the LKA has helped me to brush up on things I don’t necessarily do every day. By Nancy S.

Internal Medicine 40

Internal Medicine Board-Certified Patient-Centered Specialization 40

FDA Law Blog

MAY 19, 2023

In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device.

Specialization 40

Specialization Clinic Provider IT 40

FDA Law Blog

APRIL 25, 2023

We have recently blogged on this topic (“ Is my software a medical device? ”). Special 510(k)s. The Special 510(k) Program Guidance provides an example of a change involving the addition of wireless control capabilities to a bilevel positive airway pressure (BiPAP) device intended to treat patients with obstructive sleep apnea.

Specialization 105

Specialization Provider Medical Manufacturing 105

Family Physicians of Cedar Rapids

MAY 12, 2025

From early mornings to late afternoons, Jennifer brings compassion, dedication, and an unmatched level of care to both our patients and our team. Happy Birthday! We hope your day is filled with all the joy you bring to others. Here’s to another year of making a difference in so many lives! With love and gratitude, Your Work Family

Specialization 52

Specialization Family Families Patients 52

Dr. Michael Bazel

JANUARY 28, 2025

In this blog, we’ll explore effective strategies for setting healthy weight loss goals for the new year. A therapist, especially one who specializes in emotional eating, can also support your mental and emotional well-being during your weight loss journey. Be patient with yourself, and understand that weight loss takes time.

Physicals 130

Physicals IT Management Appointment 130

FDA Law Blog

JULY 17, 2024

We also commend and congratulate the legions of rare disease patient advocates and the leadership of the EveryLife Foundation for Rare Diseases (“ELF”) who championed the advocacy efforts that led to this important milestone. By Sarah Wicks & James E. Valentine & Frank J.

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

Vascular Physician

APRIL 22, 2024

It is commonly performed by an ultrasound technician who has been specially trained to administer ultrasound tests. Evaluate how well blood is flowing through veins and arteries Evaluate how a patient is doing after undergoing a procedure, such as having a stent placed. How Does It Work?

IT 52

IT Diagnose Specialization Healthcare 52

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.

Patient-Centered 52

Patient-Centered Diabetes Treatment Plan Insurance 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.

Diagnosis 122

Diagnosis Diagnose Hospital Clinic 122

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.

Patients 52

Patients Patient-Centered Clinic IT 52

ABIM

MAY 7, 2025

After completion of the survey period, ABIM performs a thorough review of the data with two questions in mind: Does the blueprint represent the discipline and does it represent what physicians should know to care for their patients? The last day to request a special accommodation for the fall 2025 traditional, 10-year MOC exam*.

Board-Certified Physicians 52

Board-Certified Physicians Board-Certified Provider Specialization 52

Vascular Physician

FEBRUARY 23, 2020

Vascular Institute of the Rockies 5-7 years of training after medical school specializing in learning about all aspects of peripheral vascular disease. Because vascular surgeons have the skills to provide every treatment of vascular disease, they can help individualize the treatment of each patient to what will work best for them.

Referral 40

Referral Management Complication Specialization 40

FDA Law Blog

SEPTEMBER 30, 2022

Valentine — On September 29, 2022, FDA approved Amylyx’s NDA for its drug, Relyvrio (sodium phenylbutyrate/taurursodiol), for treatment of patients with amyotrophic lateral sclerosis (ALS) (see FDA announcement here ). This is evidence of FDA’s embrace of patient-focused drug development. By Frank J. Sasinowski & James E.

Community 98

Community Provider Patients Specialization 98

FDA Law Blog

OCTOBER 2, 2024

A draft guidance issued last year focused on PCCPs for devices incorporating artificial intelligence and machine learning (AI/ML), which we blogged about here ; this guidance has not yet been finalized. FDA, Guidance for Industry, The Special 510(k) Program (2019). Draft Guidance at 34.

Medical 59

Medical Specialization Manufacturing IT 59

Vascular Physician

OCTOBER 10, 2022

Hyperbaric oxygen therapy is a type of treatment that involves a person lying in a special chamber with air pressure that is up to three times higher than normal air pressure. Hyperbaric oxygen therapy is preferred by medical professionals and patients alike thanks to the many benefits it can provide. What is Hyperbaric Oxygen Therapy?

Consulting 52

Consulting Specialization Diabetes IT 52

Vascular Physician

JUNE 26, 2022

. • Venography: This test injects a special dye into a catheter that is inserted into your posterior knee or neck. • Magnetic Resonance Imaging (MRI): This method of imaging can be used in patients for whom ultrasound is infeasible.

IT 52

IT Treatment Plan Diagnose Appointment 52

GeriPal

MAY 19, 2022

A patient is on morphine and you want to convert it to another opioid like hydromorphone (dilaudid). Dr. Akhila Reddy and colleagues study looking at converting hospitalized cancer patients from IV hydromorphone to PO morphine, PO hydromorphone, or PO oxycodone. Step four is adjusting it for your patient. How do you do that?

IT 139

IT Patients Individual Relationship 139

Vascular Physician

FEBRUARY 14, 2024

Types of Compression Therapy The two key types of compression therapy include graduated compression stockings and compression bandages: Graduated Compression Stockings These special stockings fit tighter than regular sock. As a result of a tight fit, your legs experience extra pressure, which is the highest around the ankles.

Healthcare Professional 52

Healthcare Professional Consulting Treatment Plan Healthcare 52

FDA Law Blog

SEPTEMBER 22, 2022

While the authors did a yeoman’s job of combing through the criminal cases to identify what they view as a “handful” of cases and call for increased use of the Park doctrine, we at the FDA Law Blog respectfully disagree. These intuitions about fairness weigh against policy interests designed to protect the public health.

Private Practice 59

Private Practice Government Individual Specialization 59

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”). Black Ball Freight Serv. ,

Clinic 111

Clinic IT Patient-Centered Consulting 111

FDA Law Blog

MARCH 7, 2024

NORD’s announcement followed in the footsteps of European rare disease patient organization, Eurodis , who had celebrated the first Rare Disease Day the year before. What started as a day has — due to its popularity and the persistent efforts of patients and industry — evolved into a week-long event. recognition of Rare Disease Day.

Government 69

Government Community Specialization Education 69

FDA Law Blog

FEBRUARY 18, 2025

23, 2025), DEA reviewed evidence from an administrative hearing and upheld the Administrative Law Judges (ALJs) recommended decision to revoke the registration of a pharmacy that DEA alleged dispensed controlled substances to patients without resolving numerous red flags of diversion. Whats the take away?

Government 69

Government Specialization Patients IT 69

FDA Law Blog

DECEMBER 2, 2024

Given this and the contradictions between the draft guidance, ISO 10993-1: 2018, and product specific guidance documents, use of FDA’s pre-submission process to align on necessary biocompatibility tests is recommended for devices used for short durations over multiple days or repeated use of the device by a single patient. *KP By Adrienne R.

Consulting 52

Consulting Medical Management Specialization 52

FDA Law Blog

AUGUST 18, 2024

The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use. The classification order identifies the special controls and therefore is extremely important.

Specialization 69

Specialization Hospital Physicals Provider 69

The Motivated MD

OCTOBER 10, 2024

With increasing emphasis on patient turnover and documentation, all while navigating the complexities of billing and authorization, our jobs are stressful and time-consuming. The Three Fund Portfolio This is where we ultimately return to an investment strategy I have written about previously on this blog.

Finance 52

Finance Individual Management IT 52

FDA Law Blog

MARCH 16, 2023

The inclusion of a requirement to test twice over three days with at least 48 hours between tests is consistent with study findings from the National Institute of Health published in 2022 ( LINK ); however, it is not clear if this proposed use case is practical for “point-of-care” outside of an in-patient setting.

Healthcare Professional 40

Healthcare Professional Specialization Diagnosis Transportation 40

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. Neil Baum, MD Successful practices do not follow others; rather, they make their own paths and follow their own pathways and agendas.

Management 52

Management Patient-Centered Appointment Patients 52

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. 150,000).”

Provider 64

Provider Manufacturing IT Medical 64

FDA Law Blog

FEBRUARY 27, 2023

While no “special registration” will yet be required to engage in telemedicine prescribing of controlled substances, DEA is proposing parameters to guide the practice of telemedicine encounters in a post-COVID world. a prescriber that engages in telemedicine with the patient), including a review of PDMP data for the past year.

Telemedicine 59

Telemedicine Telecommunication Telehealth Medical 59

FDA Law Blog

MAY 3, 2021

We thought this would be a good time to post a series of blog posts focusing on DEA inspections and how registrants should prepare for and manage them, with a list of registrant do’s and don’ts. We will discuss these actions in more detail in later blog. 44,710, 44,716 (July 24, 2020).

Management 52

Management Manufacturing Specialization IT 52

FDA Law Blog

MAY 4, 2023

This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ). mobile applications to capture patient-reported outcomes through questionnaires). DHTs include monitoring instruments (e.g.,

Clinic 59

Clinic Telehealth Provider Electronics 59

FDA Law Blog

APRIL 6, 2025

We are excited by Naomis strong passion for solving complex regulatory issues and ensuring patient stakeholders have a voice in the drug development process. Before her legal career, Julie worked as a nurse practitioner specializing in neurosurgery and infectious diseases.

IT 59

IT Nurse Practitioner Patient-Centered Government 59

FDA Law Blog

JULY 11, 2023

Approved in 2007 for the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy, with several indications added in the subsequent years, Somatuline Depot is a synthetic octapeptide available as ready-to-use prefilled syringes for deep subcutaneous injection.

IT 95

IT Specialization Patients 95