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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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. In some cases, having access to extra oxygen can give your body the boost it needs to speed up the healing process and restore its overall health. What is It Used For?

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The Motivated MD

DECEMBER 18, 2024

I am using our weekly blog posts to create a future book that hopefully will apply to medical trainees and early career physicians looking to build generational wealth, get out of debt, and take control of their financial lives. ’ Having a high income and being wealthy are not synonymous. What is Lifestyle Creep?

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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. The chambers are about 3 feet in diameter and 8 feet long, so they are big enough for people to enter and exit easily.

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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The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ). In such cases, performance testing may be conducted again.

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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.

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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. The JAMA editorial notes that there are few Park cases for two primary reasons: [The government] may lead.

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Reflections of a Grady Doctor

JUNE 30, 2022

One distinctly different and special from the one you had with him as a child—and unique to you and no one else? And especially thank you for the gift of showing up in every aspect of our lives—physically, emotionally, financially, collectively, and individually. Then all you’d have to do is miss him. Rest in power, sweet daddy.

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Aspiring Minority Doctor

JUNE 18, 2023

Now don't get me wrong, I am legitimately happy for all these individuals and I love seeing their success, especially when I know how hard the struggle is. I've always stayed positive on this blog, but I never did enjoy my time in my previous program. Not matching actually turned out to be one of the best things to ever happen to me.

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FDA Law Blog

MARCH 2, 2022

The revised immediately effective guidance states that products categorized as “household substances” and only intended for institutional use must be sold in special packaging under the PPPA guideline. Yet, as CPSC acknowledges, the PPPA requires certain household substances to be packaged in accordance with special packaging standards.

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FDA Law Blog

MARCH 7, 2024

Among the forty or so individuals invited to this White House event were long-time rare disease advocates like recently retired FDA Principal Deputy Commissioner Janet Woodcock, Christina Hochul of Alexion and Paul Melmeyer of Muscular Dystrophy Association. In non-leap years we celebrate on February 28 or March 1.

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FDA Law Blog

FEBRUARY 18, 2025

The discussion of the Agencys expectations of the form and substance of expert witness testimony is a must-read for entities or individuals facing a DEA order to show cause hearing. Finally, the decision explores DEAs current thinking on a pharmacists corresponding responsibility when resolving red flags. In Neumanns Pharmacy, LLC , 90 Fed.

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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 Philip Won & Adrienne R.

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FDA Law Blog

JULY 12, 2022

On June 30, individuals with access to the CCP (i.e., The email also states that the ability to submit completely electronically will first be offered to individuals with CCP accounts so that CDRH can assess the platform’s performance. the only submission type currently trackable via the CCP).

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FDA Law Blog

MARCH 16, 2023

This device is indicated for the following use: for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., In the best tradition of teasers, keep reading our blog.

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FDA Law Blog

MAY 8, 2023

See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g., here for a 510(k) device and here for a PMA device). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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FDA Law Blog

JUNE 28, 2021

On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services bill. If enacted, Article 5, Section 6 of HF33 would provide for a reduction to the State’s opiate product registration fee. 151.066, Subd.

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FDA Law Blog

JUNE 23, 2021

For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature).

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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 ). The draft guidance outlines some of the practical considerations for DCTs with regard to recordkeeping and clinical trial operations.

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FDA Law Blog

MAY 7, 2025

On April 14, 2025, the Seventh Circuit overturned the criminal conviction of Mark Sorensen, the owner of a durable medical equipment (DME) distributor, who had been found guilty of violating the AKS. Sorenson follows the Fifth Circuits decision last year in United States v. Medicare or Medicaid). In contrast to its decision in United States v.

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FDA Law Blog

MAY 20, 2021

Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. Policies and Procedures. Accountability Audit.

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FDA Law Blog

MAY 20, 2021

Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. Policies and Procedures. Accountability Audit.

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Aspiring Minority Doctor

FEBRUARY 7, 2023

I’m actually about to land soon and can barely keep my eyes open as I’ve been traveling since yesterday, but I wanted to get this started so that I can finish and hopefully post tomorrow. I figured I didn’t have a chance in hell at winning, but I shared anyway because 1) I’m always happy to share my story with hopes that it uplifts/inspires others.

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GeriPal

FEBRUARY 29, 2024

The hot sauces progressed from mild to extreme (and I mean extreme) heat. Can I just say…it works? Being asked a question with your mouth on fire, sweat streaming down your face, feeling the most awake and terrified you have ever been in your life, forces you to give an unadorned answer, straight from the heart. Lynn: Okay. Anne: GeriPal edition.

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ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Erin Bonura, MD, Chair, ABIM Infectious Disease Board The Infectious Disease Board , which meets twice a year and is responsible for oversight of ABIM policy and assessment in the specialty, held its spring meeting on March 25, 2025. The following is a summary of the spring meeting.

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New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

However, people need to understand what works best for them individually. Food has the power to regenerate the new you! The world of diets and dietary theories is complicated and can be overwhelming. Eating a diet made of whole foods, and no, not just anything you purchase from the Whole Foods grocery store.

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GeriPal

AUGUST 31, 2023

He studies the mental health system in the ways in which it has failed children and adolescents, and he writes about his experience with cancer in a blog, the Billgardner.substack.com, Billgardner, one word. ” Somebody in the comments on their blog response said, “Did you check the date? We have a Canadian theme going.

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GeriPal

APRIL 14, 2022

We got some really special guests with us. 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. It’s been around for a long time but is acting like the hot new kid in town. But does this drug really live up to the hype? Transcript. So here we go.

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PEMBlog

MARCH 27, 2024

My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. So my special guest host on this episode is a trainee in pediatrics and medical genetics. In other words, which features of the disease individuals with the mutation show for these conditions.

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GeriPal

SEPTEMBER 22, 2022

Coming off as rote and scripted during a serious illness conversation can have a similar off-putting impact on patients and families. Today we talk with Josh about how to anticipate and avoid the uncanny valley. And talk about times when we’ve fallen into it. . Key message: Listen to the music. All the time. ;). We’ll have links to it.

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GeriPal

MARCH 30, 2023

I started blogging as a patient, just talking about my own story online like patients did back in the day. But before we go into that topic, I think, Liz, you got a song request for Alex. Liz: That’s right. It’s called the Beginning of the End and it’s by Weezer. Eric: Why’d you pick this song? Eric: Lucky Strike.

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GeriPal

JUNE 29, 2023

This week we’re going on to episode two, which is for me one of the most special episodes we’ve done in GeriPal for a very, very long time. Eric: And in the end, we have a very special part where we actually get a tour of their gardens outside of the hospice unit. One story that Allan told perfectly sums this up.

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FDA Law Blog

APRIL 8, 2024

In its report, Drug Shortages: Root Causes and Potential Solutions, FDA explains that the equipment needed to produce sterile injectables is highly specialized and expensive, meaning that in a shortage situation, production capacity cannot be substantially increased without taking the time and expense of procuring and qualifying new equipment.

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GeriPal

MARCH 16, 2023

We have two authors, books, op-eds, prolific authors, and today’s podcast is a two-part special. How do you find time to write and also be doctors and academic professors? In all seriousness, you don’t actually have to want to write a book to be interested in this podcast. Welcome to the GeriPal podcast, Rosanne. And I loved it.

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FDA Law Blog

MAY 14, 2021

In 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “ Special Rule for Cigarettes.” In the same announcement, FDA also shared its intent to propose a product standard that would ban flavored cigars. 21 U.S.C. §

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FDA Law Blog

MAY 14, 2021

In 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “ Special Rule for Cigarettes.” In the same announcement, FDA also shared its intent to propose a product standard that would ban flavored cigars. 21 U.S.C. §

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FDA Law Blog

MAY 13, 2025

Weve blogged about Most-Favored-Nation (MFN) drug pricing and how the new EO goes well beyond the 2020 order and questions we have. Wasserstein We are still parsing through the May 12 Executive Order (EO), Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients and impacts this may have on the pharmaceutical industry.

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