FDA Law Blog

MAY 4, 2023

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

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FDA Law Blog

JULY 17, 2024

In December 2023, FDA established the Genetic Metabolic Diseases Advisory Committee (also called “GeMDAC,” which we blogged about here ) to advise FDA regarding treatments for genetic metabolic diseases (i.e., clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

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Barton Associates

MAY 8, 2025

In this blog, we’re going to outline four key ways temporary medical staff such as locum tenens providers can help healthcare facilities maintain continuity of high-quality patient care in the face of growing shortages. Bring specialized skills that might be otherwise lacking among permanent staff.

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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.

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FDA Law Blog

NOVEMBER 6, 2024

Starting in 2022 with a patent certification requirement, both Jazz and Avadel have sued FDA over this drug, with Jazz most recently bringing suit challenging FDA’s decision that Avadel’s Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (sodium oxybate) in 2023. The Court held that it does.

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FDA Law Blog

FEBRUARY 27, 2025

As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25. You can access the conference brochure and sign up for the event here. We look forward to seeing you at the conference.

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ABIM

MAY 7, 2025

The last day to request a special accommodation for the fall 2025 traditional, 10-year MOC exam*. These dates are only offered to candidates who have a documented disability requiring a special testing schedule, as provided under the Americans with Disabilities Act. The post News & Notes: Spring 2025 first appeared on ABIM Blog.

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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. Transparent walls allow the clinical staff to monitor the patient closely and minimize discomfort for those with claustrophobia.

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FDA Law Blog

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). Throughout the SIUU Guidance, FDA refers to studies and analyses , suggesting that publications may cover more than a description of an adequate and well-controlled clinical trial.

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FDA Law Blog

JULY 26, 2021

Clinical trials for drugs and biologics. FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The essentials of the approval process for drugs and biologics, including: INDs, NDAs, BLAs, OTC Approval, the PMA process and the Expedited Approval Process.

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FDA Law Blog

SEPTEMBER 30, 2022

Billy Dunn, the Director of CDER’s Office of Neuroscience, at the September 7, 2022 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee, applying the statutory standard in approval decisions in these clinical contexts warrants the “broadest possible” flexibility. emphasis added).

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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. Most clinical physicians are busy.

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FDA Law Blog

OCTOBER 25, 2021

It was published approximately three years after the December 7, 2018 release of the proposed rule (see blog post on the proposed rule here ). The rule became final on October 5, 2021 via publication in the Federal Register. The new rule will be codified in 21 C.F.R. Part 860. Part 807, Subpart E) and the PMA regulations (21 C.F.R.

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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. The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. Future blog posts will analyze FDA’s legal authority as well as FDA’s claimed public health need for LDT regulation.

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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

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. Each of these De Novos can represent a clinical advance. De Novos now play an important role in product advancement.

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FDA Law Blog

MARCH 16, 2023

The new regulation is listed as 21 CFR 866.3982: “Simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings.” a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis.

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PEMBlog

AUGUST 30, 2023

This is a blog post and a podcast episode 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.

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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. an administrative appeal) under 21 CFR 10.75

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FDA Law Blog

MAY 8, 2023

In addition, manufacturers should identify whether the modifications will apply to all devices in the field (referred to as global adaptations) or will be implemented based on a specific clinical site or individual patients” (referred to as local adaptations).

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GeriPal

MAY 19, 2022

It depends on the clinical situation. As I’ve been blogging about this for a couple months now, I’m really trying to find anyone who loves these things. But we still, regardless of how you do this calculation have to temper it with clinical judgment. Drew: I’ve published a draft version of it on the blog.

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FDA Law Blog

NOVEMBER 20, 2024

Exhaustive extraction in these solvents can lead to high levels of product degradation or increased levels of extractables found in the chemical data, which is not expected during clinical use, and can often result in a TRA with a negative or inconclusive outcome.

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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. The Act also established new definitions for “Internet,” “online pharmacy,” “practice of telemedicine,” among others.

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FDA Law Blog

FEBRUARY 22, 2023

The generation of HF data is a detailed and fairly burdensome process, although certainly short of a full-blown clinical study. as a de novo special control or in a guidance document for a specific device type). In one way, this is good news.

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FDA Law Blog

FEBRUARY 28, 2023

FDA announced on October 3, 2022 that the voluntary electronic Submission Template And Resource (eSTAR) templates would be required beginning October 1, 2023, as we blogged about here. There are two forms: one for non-IVD devices and one for IVD devices.

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FDA Law Blog

JUNE 21, 2021

Unable to appeal, the sponsor conducts Phase 3 using its preferred endpoint rather than FDA’s and those studies are clinically and statistically successful. You see, what is appealable is a Special Protocol Assessment (SPA) No Agreement Letter. We observed. A loophole so large that we’re not sure why we didn’t see it all along.

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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. This blog will discuss what early adopters do to implement innovative and exciting practices. or less) on an appointment card.

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ABIM

JUNE 4, 2025

Representatives from the American Association of Clinical Endocrinology (AACE), the Association of Program Directors in Endocrinology, Diabetes and Metabolism (APDEM) and the Endocrine Society joined for a portion of the meeting*. Visit the ABIM Blog for reports of prior meetings. The following is a summary of the spring meeting.

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Mesa Family Physician

JUNE 11, 2025

In this blog, we’ll break down what preventive care involves, explore its relationship with short-term health insurance, and explain why it’s a critical part of staying healthy at any stage of life. Preventive” is more commonly used in clinical and formal writing, while “preventative” is more casual. Are they the same?

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ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Some members of the Specialty Board were interested in the LKA experience, participant survey results—particularly responses about fairness—and how LKA performance data might reflect on clinical outcomes. The following is a summary of the spring meeting.

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ABIM

MAY 30, 2025

Visit the ABIM Blog for reports of prior meetings. Of note, the findings so far indicate that 90% of nephrologists who responded are clinically active. The following is a summary of the spring meeting. ABIM and the Nephrology Board gratefully acknowledge the service of Deborah B.

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FDA Law Blog

FEBRUARY 5, 2025

Validation of an AI-enabled device should also include, when feasible and appropriate, an evaluation of its repeatability and reproducibility, which may include testing using phantom, simulated, contrived, or clinical data. User Interface Software Description Section VI.B

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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. This is both a research and a clinical interest of yours. They don’t have an addiction clinic. Transcript. This is Eric Widera.

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GeriPal

FEBRUARY 29, 2024

Anne: Well, speaking of your kids, a very special, sometimes listener, chimed in named Ren Smith. But when we have people in rural areas of California, so we don’t know our clinical site, we go from San Francisco all the way to the Northern California border, super rural areas. We were a blog? Alex: Okay. Eric: All right.

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GeriPal

SEPTEMBER 22, 2022

And I think also some of the stuff we’ll be talking about, when it comes to communication, I mean, a lot of the clinical encounter is listening to the music. Tell me about the clinical enc… How do you think the uncanny valley fits into medicine and communication training and skills? What is the uncanny valley? Eric: Yeah.

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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. On clinical presentation. So what are some of these suggestive clinical features?

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FDA Law Blog

JANUARY 22, 2025

FDA deleted the requirement that SIUU be clinically relevant and left only the requirement that the information be scientifically sound (thank you FDA on behalf of industry, we are still getting used to the SASS standard from the CFL guidance and yet another evidentiary standard imposed on product communications was a bit much).

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