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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Priority Physicians

JANUARY 20, 2025

Maybe they think it’s time to consult an orthopedic surgeon for immediate joint replacement. An MRI augments and adds confidence to our clinical diagnosis. By conducting a thorough exam at our offices, we provide peace of mind and save patients money (and radiation exposure). Is an MRI Always Needed?

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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Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). They also present a more intense focus on the timelines for confirmatory study initiation and completion as well as the feasibility of those studies to verify clinical benefit within those timelines.

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FDA Law Blog

JULY 24, 2023

This time, rather than use codes and patent certifications, the fight is over orphan drug exclusivity (“ODE”), with Jazz challenging FDA’s clinical superiority decision concerning sodium oxybate in the treatment of narcolepsy. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

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FDA Law Blog

JANUARY 12, 2025

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. an intermediate clinical endpoint) and that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

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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.

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Aspiring Minority Doctor

JUNE 1, 2022

One part of me loves being able to relax at home, shower, and sleep in my own bed during my call shifts, but the other part of me did not like all the gas I used having to drive back and forth between the two hospitals I was covering for consults, or the fact that home call means no post call days. So proud of my daughter! Time flies!

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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

JANUARY 4, 2023

The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023. There was a lot of information on CMC regulatory requirements and pitfalls for cellular therapies and tissue engineered products discussed during the OTAT town hall that are not included in this blog. Comparability.

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PEMBlog

SEPTEMBER 27, 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. JAMA Pediatr. Hosp Pediatr.

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FDA Law Blog

MAY 30, 2022

Schwartz & David Chesney (DL Chesney Consulting LLC) — Things are getting hectic for those of us who advise clients on FDA inspections: FDA is busy addressing its backlog of foreign and domestic inspections. This is good news for some and bad news for others.

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FDA Law Blog

JUNE 21, 2023

Cato — On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. What medical technologies could be ideal to transition to use in non-clinical settings?

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FDA Law Blog

MARCH 3, 2024

Biotechnology services include advising or consulting services related to the use of the above equipment, disease detection, or genealogical information, or any other service for the research, development production, analysis, detection, or provision of information including data storage and transmission related to biological materials.

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Physician's Practice

JUNE 24, 2025

Reynolds Fact checked by Chris Mazzolini Blog Article Thoughtful design in medical practices enhance patient experience, boost staff productivity, and improve online reviews without major renovations. First impressions in medicine form long before anyone touches a stethoscope. 65: Patient autonomy with Jeffrey A. Singer, M.D. Singer, M.D.

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FDA Law Blog

APRIL 23, 2023

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. Outcomes of interest are more likely to be recorded in clinical records when the events are objective and require immediate medical attention (e.g., stroke).

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FDA Law Blog

FEBRUARY 23, 2025

FDA also found that analytical sensitivity and precision testing provided by Abbott was inadequate to confirm the impact of such changes on the clinical performance of its device. This can limit the type of information that can be gained from WLs.

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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. I think someone has a song request for Alex. Raele: I do. I have one. Change by Blind Melon. Eric: Why did you choose this? Eric: Fancy.

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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. KP Medical Device Consulting LLC By Adrienne R.

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PEMBlog

MAY 20, 2025

(Blooms: Apply; Kirkpatrick Level 2 Learning) Evaluate the risks and benefits of ultrasound, CT, and MRI for common pediatric emergencies and identify appropriate imaging modalities based on clinical guidelines discussed in the podcast. A lot of times when we consult a service, it’s a resident who might be at another hospital.

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PEMBlog

SEPTEMBER 6, 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. Health Aff (Millwood).

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The Clinical Problem Solvers

DECEMBER 3, 2019

Case: Mrs. G is a 66-year-old woman with a past medical history of insulin-dependent diabetes and peripheral artery disease admitted from clinic with concern for left ankle and foot cellulitis. In addition, specific clinical scenarios require other considerations. Here’s a case I saw last month where this very question came up.

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FDA Law Blog

JUNE 27, 2024

to promote therapeutic appropriateness by identifying: (a) Over-utilization or under-utilization; (b) Therapeutic duplication; (c) Drug-disease contraindications; (d) Drug-drug interactions; (e) Incorrect drug dosage or duration of drug treatment; (f) Drug-allergy interactions; [and] (g) Clinical abuse/misuse.” By Larry K.

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FDA Law Blog

SEPTEMBER 20, 2021

Some of these will be subjects of more detailed posts in the future and readers should keep an eye on the blog for additional coverage. The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries.

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FDA Law Blog

FEBRUARY 1, 2022

Another commenter suggested that FDA limit listable patents only “to patents protecting innovations that improve health and have been demonstrated to do so through clinical testing.” Finally, several commenters addressed REMS.

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PEMBlog

SEPTEMBER 13, 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

JUNE 16, 2023

The Board is not required to identify all drugs that meet the above criteria and may, in consultation with the advisory council and the commissioner of health, identify drug products that fall outside these criteria but otherwise could create “significant affordability challenges” for Minnesota’s healthcare system or Minnesota patients.

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Rao Doctor

APRIL 3, 2025

Infrared thermometers, which measure temperature from the forehead or ear, are also prevalent in clinical settings. Consulting your doctor ensures proper treatment. Mayo Clinic : Mayo Clinic’s website provides a rich repository of medical literature detailing different types of fever, their symptoms, and treatment options.

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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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GeriPal

JANUARY 18, 2024

In particular, we talk about Katie’s and Jesica’s paper in NEJM titled “ Juggling Two Full-Time Jobs — Methadone Clinic Engagement and Cancer Care ,” which described the difficulty in managing cancer pain and methadone for opioid use disorder. And you wrote, actually, a beautiful GeriPal blog about it a while ago. What is it called?

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GeriPal

APRIL 14, 2022

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. Eric: And why Under Pressure. Alex: So we’ll see what these come out like.

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GeriPal

DECEMBER 8, 2022

Eric’s blog post on Dignity Therapy from 2011. So those questions we ask when we’re doing a palliative care consult. And then we also have another Vas, many of the interviews are done by medical students or other healthcare trainees as part of their clinical rotation at the VA. About us – Dignity in Care.

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PEMBlog

MARCH 27, 2024

She is a member of the Clinical Genome Resource Inborn Errors of Metabolism (IEM) Clinical Domain Working Group, where as a biocurator she assesses the pathogenicity of variants in IEM-associated genes to facilitate expedited genetic diagnosis for IEMs. On clinical presentation. your genetics consult hasn’t responded yet.

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FDA Law Blog

JULY 7, 2024

The guidance restates the central premise of the final rule, i.e., that LDTs are medical devices and the clinical laboratories that design, manufacture and use them to test patient specimens are manufacturers. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R. 820.198). .

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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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Illness IT Patient-Centered Patients 101

FDA Law Blog

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). intended use population.

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GeriPal

DECEMBER 15, 2022

So those questions we ask when we’re doing a palliative care consult. And then we also have another Vas, many of the interviews are done by medical students or other healthcare trainees as part of their clinical rotation at the VA. Working with our clinical decision support team and thinking about where that could be.

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FDA Law Blog

MARCH 15, 2023

By updating the mammography regulations, FDA sets a minimum standard that patients be informed of whether they have dense or non-dense breast issue and the significance of breast density and suggest that patients consult their doctors about the need for additional tests. The final rule will be effective on September 10, 2024.

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