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.

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Dr. Michael Bazel

JANUARY 28, 2025

In this blog, we’ll explore effective strategies for setting healthy weight loss goals for the new year. This approach also provides opportunities to celebrate small wins along the way, which can help keep you motivated. 3-4 months : Lose another 7 pounds. 5-6 months : Reach the final 8 pounds of your goal.

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ABIM

MAY 7, 2025

Blueprints provide an outline of what content will appear on an assessment and the relative percentage of the assessment covered by each topic area. During this process, Item-Writers will often provide feedback and societies provide their own perspectives on behalf of their members.

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FDA Law Blog

AUGUST 23, 2021

These revisions appear to be responsive to a November 16, 2020 Special Fraud Alert issued by the Office of Inspector General at the U.S. Department of Health and Human Services (OIG) (see our blog post on this Special Fraud Alert here ).

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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. Wearing sandals around the pool is okay, but avoid wearing them daily as they do not provide adequate support for your feet. Consider trying a sandal with arch support.

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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.

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FDA Law Blog

OCTOBER 6, 2023

There is much to unpack, and we intend to do so in a series of blog posts. Given the potentially massive impact of the proposed changes on a wide range of stakeholders, and indeed on the healthcare system, we strongly encourage interested parties to submit comments, which can be done using the provided link.

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FDA Law Blog

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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Vascular Physician

JUNE 26, 2022

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. • Venography: This test injects a special dye into a catheter that is inserted into your posterior knee or neck.

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FDA Law Blog

MARCH 9, 2025

The conference is the premier event on cosmetics and personal care products, where industry leaders will provide essential updates on compliance with Modernization of Cosmetics Regulation Act of 2022 (MoCRA), state legislative reforms, and new FTC advertising guidelines. FDA Law Blog is a conference media partner.

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FDA Law Blog

FEBRUARY 13, 2025

The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ). FDA provides definitions for the three datasets.

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Vascular Physician

DECEMBER 11, 2023

Diagnosis and Treatment of AVFs AVFs are diagnosed by a healthcare provider. If the healthcare provider suspects you have an AVF, they will request other tests to confirm it. If the healthcare provider suspects you have an AVF, they will request other tests to confirm it.

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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. FDA is extending the comment period on the notice published September 20, 2024 ( 89 FR 77162 ).

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FDA Law Blog

JANUARY 24, 2024

The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. Karst (Director, Hyman, Phelps & McNamara, P.C.) The discount code is: D10-999-FDA24.

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East Cary Family Physicians

JANUARY 30, 2024

As we embark on Glaucoma Awareness Month, East Cary Family Physicians is unwavering in our commitment to highlight the pivotal role of vision health, with a special emphasis on the early detection of glaucoma. Glaucoma, often referred to as the “silent thief of sight,” can lead to irreversible vision loss if left untreated.

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FDA Law Blog

FEBRUARY 27, 2025

The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. As such, we can offer our readers a special 10% discount. And it is exactly that! The discount code is: D10-999-FDA25. You can access the conference brochure and sign up for the event here.

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Vascular Physician

NOVEMBER 28, 2023

Other signs of lymphedema include: Feeling tightness or heaviness in the affected area Thickening of the skin Frequent infections It is best to schedule an appointment with your healthcare provider as soon as you notice one or more symptoms of lymphedema. Early diagnosis could mean a more effective treatment plan.

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FDA Law Blog

MARCH 3, 2025

From funding innovations and AI in drug discovery to navigating legal and compliance challenges, this conference will provide you with the opportunity to gain the insights you need to drive scientific advancements to global market success. FDA Law Blog is a conference media partner. Hyman, Phelps & McNamara, P.C.s

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FDA Law Blog

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. So, what is special about September 24, 2023? Most of the compliance dates have been passed.

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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?

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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.

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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.

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FDA Law Blog

JULY 26, 2021

The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: D10-806-806GX02. We look forward to seeing you at the conference.

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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

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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FDA Law Blog

SEPTEMBER 30, 2022

Dunn suggested that we look to FDA’s previous approval decisions to understand just how much uncertainty can be accepted, sighting in ALS to previous approval decisions that did not provide traditional efficacy evidence. We would like to acknowledge FDA for its efforts on this devastating condition, ALS. emphasis added).

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FDA Law Blog

OCTOBER 31, 2022

We have followed it over the last five years, with blog posts here , here , here , here , here , here , and here. It was noted that authorizing a device through a De Novo would create pilot specific special controls that other companies would need to follow, even if not participating in the pilot program. Key Findings at 12.

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FDA Law Blog

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. FDA Law Blog is a conference media partner for this event. The discount code is: S10-826-826L24.S.

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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.

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FDA Law Blog

SEPTEMBER 25, 2024

It provides a perspective on Hatch-Waxman that only a few folks out there (and dwindling) can provide.

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FDA Law Blog

APRIL 14, 2022

Over the course of two days, this event will provide impactful and practical programming all geared towards assessing the implications and imprimaturs of court cases, legislation, and industry behaviors which affect the patent endgame and the pursuit of related profits. FDA Law Blog is a conference media partner.

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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. Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. By Day 90 FDA sends final MDUFA Decision on 510(k).

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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.

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The Motivated MD

OCTOBER 10, 2024

So, with this chapter, I hope to briefly touch on the basics of market investing and describe why simple diversification and index fund investing are the most effective ways for busy clinical physicians and healthcare providers to invest with the expectation of long-term gains. Don’t try to beat the market; be the market.

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FDA Law Blog

DECEMBER 7, 2023

There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention. 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.

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FDA Law Blog

MAY 4, 2023

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. 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 ).

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FDA Law Blog

SEPTEMBER 29, 2021

ACI’s Paragraph IV Disputes Conference provides invaluable professional development opportunities, meaningful networking, and vital “take-aways” for legal strategies and cost analysis for every aspect of this complex form of litigation. FDA Law Blog is a conference media partner. The discount code is: D10-895-895AX04.

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