Vascular Physician

OCTOBER 10, 2022

Here's what you should know about the risks and benefits of hyperbaric oxygen therapy before scheduling your complimentary consultation with the trusted team at the Vascular Institute of the Rockies. Hyperbaric oxygen therapy is preferred by medical professionals and patients alike thanks to the many benefits it can provide.

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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? What Causes Varicose Veins?

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Vascular Physician

APRIL 22, 2024

Whether you are showing signs of a vascular concern, have been diagnosed with a disease, or are striving to prevent a vascular illness from occurring in the future, a vascular ultrasound can give your healthcare provider a clear image of how well blood is flowing to the organs and tissues throughout your body.

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Vascular Physician

FEBRUARY 14, 2024

If you have arterial disease, please consult your physician before using compression therapy, as this may be contraindicated for some patients. To create a personalized treatment plan and start addressing your venous circulation issues immediately, please schedule a consultation today. Can compression therapy be used during pregnancy?

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Priority Physicians

JANUARY 20, 2025

Priority Physicians Provides Care for Musculoskeletal Injuries But before you rush that sprained ankle to urgent care, consider this: At Priority Physicians, we have fellowship-trained sports medicine doctors with the proper credentials to handle musculoskeletal injuries knowledgeably.

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Vascular Physician

FEBRUARY 14, 2024

Before the Procedure If you have been diagnosed with carotid artery disease or atherosclerosis, your healthcare provider may recommend a carotid endarterectomy to reduce your risk of having a stroke, which is the main risk with carotid artery disease. Prior to the procedure, you will have a consultation and evaluation.

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FDA Law Blog

NOVEMBER 20, 2024

The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting. KP Medical Device Consulting LLC By Adrienne R.

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FDA Law Blog

MAY 29, 2025

According to the global consulting group ICF, the pilot used an ICF-developed Computerized Labeling Assessment Tool (CLAT) to read drug labels and pinpoint specific items for review, with the goal of improving the effectiveness of the drug labeling review.

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Vascular Physician

JUNE 26, 2022

Here's what you should know before scheduling your consultation at the Vascular Institute of the Rockies. If your healthcare provider suspects that you could have DVT, they will likely perform a series of tests to provide you with a diagnosis and personalized treatment plan. What is DVT? What Are the Treatment Options for DVT?

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East Cary Family Physicians

JANUARY 30, 2024

In this blog post, we’ll explore the importance of vision screenings, especially during Glaucoma Awareness Month, and how they play a crucial role in preserving your eyesight. Consult with your primary care physician before starting a new workout routine, ensuring it aligns with your specific health needs.

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Vascular Physician

JUNE 12, 2022

Here's what you should know about claudication before scheduling your consultation with the experts at the Vascular Institute of the Rockies. Contact us today to schedule your consultation. If you experience pain or discomfort whenever you walk or exercise, it may be a sign of a condition known as claudication. What is Claudication?

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Vascular Physician

NOVEMBER 5, 2023

Common CVI symptoms include: Swelling in the affected areas Varicose veins Leg pain, heaviness, and fatigue Skin changes and ulcers If you notice one or more of these symptoms, be sure to schedule a consultation with your healthcare provider to get your symptoms under control and prevent the condition from worsening.

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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. FDA), and to generate data in a format that would streamline FDAs review.

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Vascular Physician

DECEMBER 21, 2022

Schedule Your RAS Consultation at The Vascular Institute When it comes to protecting the health of your renal arteries, there's no time to waste. First, they will perform a physical exam, review your health history, and check your kidney function with blood and urine tests.

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FDA Law Blog

JANUARY 30, 2025

Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials. Tobolowsky & Charles G. Raver & James E.

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Family Physicians of Greeley

MAY 17, 2023

In this blog, we will explore effective strategies for improving mental health and nurturing a positive mindset. If you struggle with sleep difficulties, consider implementing relaxation techniques or consulting with a healthcare professional. Maintaining good mental health is essential for our overall well-being.

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FDA Law Blog

NOVEMBER 10, 2024

The Agency announced the FY2024 funding for the three natural history study grant awardees provides $4.7 The Clinical Trials Grants Program provides funding for clinical trials that evaluate the safety and efficacy of potential treatments for rare diseases to help move promising treatments through clinical development.

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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. 2014;58(2):258-274.

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FDA Law Blog

DECEMBER 2, 2024

We have seen this come up in many device reviews over the last several years, so we are not surprised to see it make its way to the draft guidance, but the justification for this burdensome approach is not provided and having conflicting recommendations in two related documents (i.e., KP Medical Device Consulting LLC By Adrienne R.

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FDA Law Blog

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. As such, we will publish a separate blog post focused on confirmatory trials and how FDA is interpreting this key provision of its accelerated approval authority.

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FDA Law Blog

FEBRUARY 21, 2024

As readers of this blog may recall, this PPM dates from 1998. 1842 ) (Innovative FEED Act), introduced in 2023, would amend the FDC Act to provide CVM with the required authority. By Riëtte van Laack — On Feb. It reflects CVM’s narrow interpretation of what constitutes a permissible structure function claim for an animal food.

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FDA Law Blog

DECEMBER 7, 2023

In his conference keynote address , Arun Rao—the Deputy Assistant Attorney General for DOJ’s Consumer Protection Branch—provided an overview of DOJ’s year in FDA enforcement. We’ve blogged on VSDs previously here and here , as the application of the VSD for FDA-regulated industry has been vexing.

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FDA Law Blog

JUNE 27, 2021

Consult with Human Resources and employment counsel on requests from DEA for personal employee information. Provide unavailable information and records or reports requested by the investigators as soon as possible if appropriate to do so. Do not surrender a DEA registration without consulting an attorney.

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FDA Law Blog

AUGUST 23, 2021

Department of Health and Human Services (OIG) (see our blog post on this Special Fraud Alert here ). The new Code continues to permit incidental meals that are modest by local standards (still without defining “modest”), but adds a prohibition on providing alcohol. Grab-and-go” meals and alcohol are not appropriate.

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FDA Law Blog

NOVEMBER 6, 2024

Though Jazz alleged that the Sleep Team consultation departed from OOPD’s standard operating procedures, the Court found this unsupported by the Administrative Record. And, the Court said, Jazz’s critiques of FDA’s findings do not “rise[] to arbitrary and capricious agency decision-making.”

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FDA Law Blog

SEPTEMBER 17, 2023

For example, device sponsors can request a meeting with an FDA review team by submitting a pre-submission to CDRH (see our recent blog on the minor updates to the Pre-Submission Guidance). Once your request for an in-person or hybrid meeting is agreed upon, you are expected to provide a list of in-person and virtual attendees.

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FDA Law Blog

JANUARY 5, 2022

Prior to joining HP&M, Adrienne worked as an independent regulatory consultant and consultant with Emergo. As a Principal Medical Device Regulation Expert, Adrienne will continue to provide consulting to medical device and combination product manufacturers.

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FDA Law Blog

FEBRUARY 23, 2025

To help in evaluating device changes, manufacturers commonly refer to FDAs guidance Deciding When to Submit a 510(k) for a Change to an Existing Device, which provides FDAs interpretation of the changes it believes could significantly affect the safety or effectiveness of a device. But this guidance has its limitations.

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PEMBlog

MAY 20, 2025

We really do have so many resources at our disposal, and it is very hard for them to know everything about kids and adults while practicing in locations where they don’t have these consultants available 24/7. And so we routinely do outreach with our community providers. So I’ll give you a couple of examples.

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FDA Law Blog

JANUARY 5, 2022

Prior to joining HP&M, Adrienne worked as an independent regulatory consultant and consultant with Emergo. As a Principal Medical Device Regulation Expert, Adrienne will continue to provide consulting to medical device and combination product manufacturers.

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FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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FDA Law Blog

NOVEMBER 7, 2024

If a company and/or their regulatory consultant(s)/counsel have evaluated the product and determined it is not a device, the company can decide to proceed to market the product without contacting FDA. Sometimes, though, the question of classification defies an easy answer.

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FDA Law Blog

JUNE 28, 2023

As part of that effort, Accreditation Scheme for Conformity Assessment (ASCA) is designed to reduce FDA review time, reduce and/or remove Sponsor guesswork on documentation to provide in a premarket submission, and improve the quality of testing conducted.

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FDA Law Blog

APRIL 22, 2025

By law, DEA must provide you with notice and an opportunity for a hearing before it can take away your registration (or deny your application), so DEA will issue an Order to Show Cause, which explains the legal grounds for revoking or denying a registration and informs you of your right to challenge DEAs decision.

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FDA Law Blog

FEBRUARY 5, 2024

She also provides consulting services for state licenses, as well as regulatory due diligence concerning licensing requirements, primarily for pharmaceutical manufacturers, wholesale distributers, and pharmacies.

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FDA Law Blog

MARCH 7, 2023

As most in the device industry know, preparing a 510(k) is typically a collaborative process—with multiple functions, consultants, and levels of management often involved in its review and creation. However, not providing the appropriate type of information and level of detail the Agency expects is still possible with eSTAR.

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FDA Law Blog

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. In case you do not have time to watch the town hall , we provided a summary of select topics that are discussed below.

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