Family Medicine Initiative

APRIL 9, 2024

Both the FDA and EMA recommend that doctors monitor patients with diabetic retinopathy who are undergoing semaglutide treatment closely. 10 , 9 In patients with uncontrolled or potentially unstable diabetic retinopathy, treatment with semaglutide 2.4 mg is not recommended. 9 The American Academy of Ophthalmology offers more information here 11.

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Diabetes Patients Medical DO 130

The Clinical Problem Solvers

SEPTEMBER 2, 2020

Blog post – by Smitha Want to test your learning? The immune reconstitution inflammatory syndrome (IRIS) is a potential complication of antiretroviral therapy (ART), wherein patients with advanced immunosuppression related to HIV develop an inflammatory response (generally to microbial antigens) as their immune system recovers.

Clinic 52

Clinic Diagnosis Complication Internal Medicine 52

The Clinical Problem Solvers

AUGUST 25, 2019

Clinical Manifestations We often think of GPA as a pulmonary-renal syndrome, but, while many patients develop renal complications, a much smaller percentage present with them. A lung biopsy demonstrated necrotizing granulomatous inflammation, and a diagnosis of GPA was made.

Illness 52

Illness Complication Diagnosis Clinic 52

Plum Health

MAY 19, 2023

Transparent Pricing: With DPC, you know exactly what you're paying for - no hidden costs, no complicated insurance bills. This blog post is a general informational guide and does not replace professional medical advice, diagnosis, or treatment.

Primary Care 52

Primary Care Insurance Medical Advice Healthcare 52

Vascular Physician

NOVEMBER 5, 2023

Complications Associated with Chronic Venous Insufficiency While CVI is not considered to be life-threatening, it can have a negative impact on the way you look and feel. CVI can lead to complications that can make performing normal daily activities difficult. When this happens, blood can flow backward and lead to pooling in your legs.

Complication 52

Complication Appointment Management Healthcare 52

Vascular Physician

DECEMBER 21, 2022

Because of this, it is important to address vascular complications as soon as they arise, including Peripheral Arterial Disease (PAD). If left untreated, PAD may progress over time and can lead to more serious health complications. Maintaining a healthy circulatory system is a critical part of living a long, healthy life.

Treatment Plan 52

Treatment Plan Appointment Complication Diagnose 52

Vascular Physician

DECEMBER 2, 2020

Other more complicated cases may require open interventions such as endarterectomy and/or bypass. Overall, this procedure may seem quite complicated, but a large team of medical experts are involved in the care of each patient. Some cases may be treated with minimally invasive techniques such as endovascular stenting and angioplasty.

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Medical Student Complication Hypertension Utilities 52

Vascular Physician

NOVEMBER 28, 2023

This is because both diabetes and PAD have many of the same risk factors and complications. If you have been diagnosed with diabetes, keeping your blood sugar under control is a proactive way to lower your risk of developing PAD or other complications including stroke and heart attack.

Diabetes 40

Diabetes Diagnose Treatment Plan Complication 40

Vascular Physician

FEBRUARY 14, 2024

Undergoing carotid endarterectomy can help reduce your risk of experiencing serious complications from carotid artery disease, including a stroke. It is also important to be aware of potential complications following your surgery. This includes eating a balanced diet, exercising regularly, and not smoking.

Complication 52

Complication Diagnose Appointment Healthcare 52

Vascular Physician

MARCH 10, 2022

Early diagnosis and treatment can help prevent more serious complications from developing. Diagnosing PAD and PVD as early as possible is critical to preventing further plaque buildup that can lead to serious complications, including heart disease and stroke. PAD vs PVD: What's the Difference?

Diagnose 52

Diagnose Complication Diagnosis Appointment 52

The Clinical Problem Solvers

MAY 14, 2020

The second major factor complicating our diagnostic reasoning during this time is the dramatic shift in prevalence of the disease in the community. As described by my friend Jack Penner elsewhere in this blog series, a core tenet of analytic reasoning involves interpretation of the pretest and posttest probabilities of a disease.

Illness 52

Illness Diagnosis Emergency Room Diagnose 52

Vascular Physician

APRIL 22, 2024

An aortic dissection may also cause a rection in blood flow to other parts of the circulatory system, often resulting in additional complications such as stroke, heart attack, renal failure, or spine and nerve damage. Unfortunately, high blood pressure does not always present with symptoms that are noticeable by the patient.

ER 52

ER Hypertension Primary Care Medical 52

Vascular Physician

JUNE 27, 2021

blog h2 { margin-top: 1.25rem; } With more than 40 million people suffering from the pain and embarrassment that comes from living with varicose veins, you may be wondering: can anything be done to manage these negative effects at home, or is professional intervention the only solution for varicose veins?

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Consulting Treatment Plan Management Complication 52

GeriPal

MAY 19, 2022

Summary Transcript Summary. A patient is on morphine and you want to convert it to another opioid like hydromorphone (dilaudid). How do you do that? Do you do what I do, pull out a handy-dandy opioid equianalgesic table to give you a guide on how much to convert to? . which advocates for an updated, wait for it… equianalgesic table! . Drew: Yeah.

IT 139

IT Patients Individual Relationship 139

FDA Law Blog

JULY 13, 2022

With 190 pages dedicated to prescription drug pricing reform, the program is ambitious…and complicated. Karst — The Build Back Better Act—the food and drug law implications of which we discussed last year —has popped up again in Congress, and it is just as dense as ever.

IT 52

IT Manufacturing Utilities Complication 52

FDA Law Blog

SEPTEMBER 11, 2024

FDA recognizes that nitrosamine detection and remediation are complicated undertakings for quality managers. By John W.M. Claud — Last week, FDA revised one of its two guidances relating to nitrosamines, Control of Nitrosamine Impurities in Human Drugs. Using the guidelines found in the ICH M7(R2) , FDA set an AI threshold of 1.5

Manufacturing 105

Manufacturing Management Complication Provider 105

Vascular Physician

JUNE 12, 2022

If you are diagnosed with claudication, your healthcare provider will likely create a personalized treatment plan to help relieve your symptoms, reduce pain, and reduce your chances of experiencing other complications, such as heart disease. When your arteries are not healthy, your overall quality of life can be affected. What Are the Causes?

Treatment Plan 52

Treatment Plan Consulting Diabetes Individual 52

FDA Law Blog

AUGUST 9, 2021

This could get complicated though, as FDA explains that the transition may affect program fee tier assessments for ANDA holders or facility fees. The FDCA definition hinges on the mechanism by which a product meets its primary intended purposes. Sponsors can then request a refund.

IT 52

IT Medical Complication Provider 52

Vascular Physician

MARCH 6, 2023

The most common complication from venous disease is a lower quality of life due to symptoms. Here's what you should know about how diseases affecting your veins, also known as venous diseases, could impact you. What is Venous Disease? They are essentially hollow tubes with thin walls and special flaps inside them called valves.

Transportation 52

Transportation Diagnose Management Appointment 52

Vascular Physician

APRIL 25, 2022

aneurysms or post-surgical complications). Although recurrent hemarthrosis and osteoarthritic pain are the two most studied conditions, there may be other experimental indications for this procedure (e.g., Typically, GAE is a short procedure, lasting between 60-90 minutes, and it is performed during an outpatient visit.

Complication 40

Complication Patients Provider IT 40

FDA Law Blog

JANUARY 15, 2024

FDA explained that “cartridge-based” products are more attractive to youth than “open tank systems,” which are bigger, harder to conceal, more complicated, and require refilling. FDA originally set the PMTA deadline as August 8, 2022, but a district court in Maryland ordered FDA to shorten it.

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Manufacturing IT Provider ER 115

FDA Law Blog

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.

Complication 64

Complication IT Provider 64

The Clinical Problem Solvers

FEBRUARY 9, 2020

Clinical Reasoning Corner: Likelihood Ratios By Jack Penner Welcome back, Clinical Problem Solvers! Thank you for reading the latest post in our “Clinical Reasoning Corner”, where we discuss key clinical reasoning principles that shape how we think through cases. Today, we’re going to talk about likelihood ratios – let’s dive in!

Clinic 52

Clinic Diagnosis Hypertension Patients 52

FDA Law Blog

AUGUST 16, 2022

He added that FDA’s foreign offices have also resumed performing inspections for nearly six months now, except in China, where Zero-COVID policies complicate logistics and scheduling. Mr. Cruse pledged that the frequency of these inspections would increase.

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Manufacturing Complication Medical IT 98

Vascular Physician

MARCH 29, 2022

Extensive imaging is done prior to the surgery to assess a patient's risk and help them prepare for the success and possible complications of the surgery. A carotid body tumor is a growth in your neck located next to the carotid artery, which is the vessel that carries blood to parts of your brain and face. Who is at Risk?

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Family Families Complication Patients 40

Vascular Physician

OCTOBER 10, 2022

Imaging studies may also be ordered and help your physician determine the likelihood of successful surgery and possible complications. Treatment is patient-specific and based on age, health, and severity. There are several options for treatment, and these management choices may help slow the progression of symptoms.

Hypertension 52

Hypertension Complication Patients Diagnosis 52

Vascular Physician

AUGUST 19, 2021

When left untreated, TOS can cause more serious complications, including permanent arm swelling and pain, blood clots, pulmonary embolism, and permanent nerve damage. It gets its name from the Thoracic Outlet that is located between the lower neck and upper chest and this collection of blood vessels and nerves can be found.

Diagnose 40

Diagnose Treatment Plan Management Complication 40

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. Eric: Alex, we got a great show today on Dysphagia Revisited. Who do we have on with us today? Eric: Oh boy. Alex: It’s back.

IT 124

IT Patient-Centered Hospital Individual 124

FDA Law Blog

JULY 10, 2023

In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. By Philip Won & Adrienne R. But that is only the beginning.

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Provider IT Engineering Medical 75

FDA Law Blog

JANUARY 8, 2024

Deals in FDA regulated space are among the most complicated of any industry, and diligence adds cost. Interest rates may be on the way down, which in turn may mean that more capital will free up and thus more deals may be in the offing. If this all holds true, it will follow the upward trend of the 2023 year in deals.

Complication 69

Complication Government IT 69

FDA Law Blog

DECEMBER 13, 2023

GeMDAC’s mandate is to advise the Agency on these complicated issues in this challenging area of medical product development. Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.” Note that FDA is currently soliciting applications to staff this committee.

Patient-Centered 59

Patient-Centered Medical Patients IT 59

FDA Law Blog

AUGUST 22, 2023

On the heels of a nuanced and more complicated Warning Letter addressing CFL claims and statistical presentations comes a new Untitled Letter from OPDP going back to its roots ! By Dara Katcher Levy — OPDP is coming out ! So, what gives? NAD appeared to be inviting pharmaceutical companies to leverage its processes and submit complaints.

Healthcare Professional 40

Healthcare Professional Healthcare IT Complication 40

FDA Law Blog

JULY 29, 2024

Last week, FDA issued draft guidance to address the potential complications that arise when sponsors seek to modify products, production processes, or quality controls for approved biologics license application (BLA) biosimilar and interchangeable products. We’ll update this post when FDA issues Final Guidance.

Manufacturing 64

Manufacturing Complication Government IT 64

FDA Law Blog

JUNE 30, 2022

As the drug distribution industry is well aware, and as blogged about here , on February 4, 2022, FDA published its long-awaited proposed rule titled “ National Standards for the Licensure of Wholesale Drug Distributors and Third-party Logistic Providers ” (87 Fed. Palmer & John A.

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Supply Chain Provider Government Complication 52

FDA Law Blog

DECEMBER 6, 2023

And yet, under the proposed rule, FDA is expecting a far greater surge, for a longer period of time, of far more complicated submissions. Congress has, on multiple occasions , considered legislation that would have given FDA that authority, but it never did so. Based on the COVID experience, this is a recipe for gridlock and chaos.

Engineering 59

Engineering Medical Complication IT 59

FDA Law Blog

AUGUST 11, 2024

The approved labeling for AUVI-Q includes warnings and precautions regarding emergency treatment, injection-related complications, serious infections at the injection site, allergic reactions associated with sulfite, and disease interactions. The second Untitled Letter was issued to Mirati Therapeutics Inc.

Clinic 59

Clinic Provider IT Complication 59

FDA Law Blog

JANUARY 11, 2024

Koblitz — Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”). Notably, the purpose of the statute seemed to govern much of FDA’s interpretation.

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Provider IT Manufacturing Complication 59