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. At-home medical technologies include, but are not limited to, monitoring and wearable devices (e.g.,

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FDA Law Blog

DECEMBER 16, 2024

Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. By Adrienne R. FDA), and to generate data in a format that would streamline FDAs review.

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The Clinical Problem Solvers

APRIL 24, 2025

Simon is a pediatric addiction medicine psychiatrist at Boston Children’s Hospital; an assistant professor in psychiatry at Harvard Medical School; a recent Commonwealth Fund fellow in health policy at Harvard University; and the medical director of Wayside Youth & Family Support Network.  2023 Apr;21(2):166-7. Benton TD.

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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.

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FDA Law Blog

JUNE 28, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.

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FDA Law Blog

NOVEMBER 7, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. According to the latest MDUFA performance report , only 25% of 513(g)s in fiscal year 2023 met the 60-day statutory time frame. Sometimes, though, the question of classification defies an easy answer.

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FDA Law Blog

JANUARY 30, 2025

The January 2025 draft guidance, however, provides a more focused discussion of the timing of confirmatory studies and how that might impact approval. Meeting these benchmarks prior to the accelerated approval action date would provide FDA with greater assurance of the trials feasibility and timely completion.

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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. For example, in an October 13, 2023 WL to ReNovo, Inc.,

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FDA Law Blog

SEPTEMBER 17, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — Over the last three and a half years, meetings with FDA were conducted virtually. If FDA is slow in providing that list, it is fine to send a follow-up email requesting a list of FDA attendees in advance of the meeting. Be ready with backup options (e.g.,

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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

JUNE 27, 2024

After issuing an Order to Show Cause and Immediate Suspension of Registration in September 2022, and an administrative hearing in March 2023, DEA adopted the hearing Administrative Law Judge’s (“ALJ’s”) Recommended Decision to revoke Coconut Grove’s registration based on the public interest factors of 21 U.S.C. 21 U.S.C. § a), 1306.06.

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FDA Law Blog

APRIL 23, 2023

Outcomes of interest are more likely to be recorded in clinical records when the events are objective and require immediate medical attention (e.g., If sponsors do not own the data used for the external control arm, they should structure agreements with the data owner to ensure that patient-level data can be provided to FDA.

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Physician's Weekly

JUNE 19, 2025

Pregnant with her second child, she schleps a backpack instead of a traditional black bag to carry a laptop and essential medical supplies — stethoscope, blood pressure cuff, and pulse oximeter. “We step into places where other providers may not, and geriatrics is a prime example of that.”

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Doctor On Demand

APRIL 28, 2025

Urgent care clinics provide quick diagnoses and treatments, including antibiotics if needed. These symptoms require immediate medical attention. Changes in voice (“hot potato” voice) Speaking in a muffled, strained voice, which some doctors call a “hot potato” voice, indicates severe swelling in the throat that needs medical attention.

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Physician's Weekly

JUNE 19, 2025

About 3 in 10 adults reported not taking their medicines as prescribed at some point between July 2022 and July 2023 because of the cost, according to a KFF survey. When Bob changed jobs, the price tag for his daughter’s medication went through the roof. They started trying out different medications and dosages.

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GeriPal

JANUARY 16, 2025

These individuals may become unrepresented, meaning they lack the capacity to make a specific medical decision, do not have an advance directive for that decision, and do not have a surrogate to help. We’re going to be talking about the American Geriatric Society position statement on making medical treatment decisions.

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GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. So medication adjustments.

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PEMBlog

MARCH 27, 2024

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families. Updated 2023 Jul 17]. Pediatr Rev.

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FDA Law Blog

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. According to Dr. Shuren, the TAP Advisor acts as a consultant, engaging with companies to identify key questions, challenges, and areas requiring strategic problem-solving.

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GeriPal

MARCH 24, 2023

JAMA IM 2023 A shout-out to my NPR episode on 1A titled the “State of Hospice Care” DISCLAIMER While we filmed in Montreal during the Annual Assembly, all opinions expressed in this podcast are independent of AAHPM and HPNA, or the Annual Assembly. She happened to focus on some specific for-profit hospice providers. JAMA Health Forum.

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FDA Law Blog

JULY 9, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate. 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). intended use population.

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GeriPal

MARCH 6, 2025

link] Toronto Star Feature [link] CityNews Toronto Feature [link] Psychosocial Interventions at PEACH In addition to medical care, PEACH also runs two key psychosocial interventions for our clients: PEACH Grief Circles Structured spaces for workers in the homelessness sector to process grief. those experiencing homelessness).

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PEMBlog

JANUARY 16, 2025

Learn how to recognize and manage cases in the emergency department, ask the right questions to uncover inhalant use, and provide critical resources for prevention and support. Clin Toxicol (Phila) 2023; 61:453. Its evolved from its medical and industrial applications to a recreational substance with a significant cultural footprint.

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FDA Law Blog

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.)

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New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

Eating fruit provides excellent health benefits and is part of a healthy plate. Fruits provide nutrients vital for health and maintenance of your body. Fiber containing foods such as fruits help provide a feeling of fullness with fewer calories. Then take a moment to reflect on your unique plate. What similarities do you notice?

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GeriPal

SEPTEMBER 5, 2024

And he’s also chaired the California Pacific Medical Center’s ethics committee since 1985. Louise 05:02 Yes, well, I don’t know about 2024, but in 2023, yes, it could happen. And it’s not the same, but it does provide information. Bill, welcome to the GeriPal podcast. Bill 00:53 Thank you, Alex.

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FDA Law Blog

JUNE 10, 2025

The agency revised the list in October 2023 when it added twenty-eight chemicals, removed two List I chemicals automatically included as a laboratory supply and added “tableting machines, including punches and dies.” One commenter, without providing details, asserted that the chemical may have uses in the medical field.

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FDA Law Blog

JANUARY 24, 2024

Fast-forward to March 2023, when The White House OSTP issued a document per Executive Order 14081, titled “ Bold Goals for U.S. As the report explains: This report provides a vision for harnessing research and development (R&D) advances in biotechnology and biomanufacturing to build supply chain resilience. bioeconomy.”

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Physicians News Digest

MAY 12, 2025

31 that a New York physician had been indicted for shipping abortion medications to a woman in Louisiana, it stoked fear across the network of doctors and medical clinics who engage in similar work. It was unclear when those tests would come, and would it be against an individual provider or a practice or organization?”

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PEMBlog

APRIL 4, 2025

And so I do encourage you to be familiar with some of the information provided by the CDC as long as it’s still online. So as of the 2023-24 school year, about 3.3% 2023 translates to about 80,000 kids in the United States, and vaccination coverage varies across states. So in the 2023-24 school year. Unfortunately.

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GeriPal

JULY 20, 2023

See the AAHPM Legislative Action Center [link] Write to the DEA, with guidance from AAHPM’s comments to the DEA March 2023. Alex: We are delighted to welcome Joe Rotella, who’s the Chief Medical Officer of the American Academy of Hospice and Palliative Medicine. What was life for you as a provider pre-pandemic?

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Physician's Weekly

JUNE 17, 2025

By the time Eric Tennant was diagnosed in 2023 with a rare cancer of the bile ducts, the disease had spread to his bones. But that’s when his family began fighting another adversary: their health insurer, which decided the treatment was “not medically necessary,” according to insurance paperwork. BRIDGEPORT, W.Va. —

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Physicians News Digest

APRIL 3, 2025

Survey data gathered by AHRQ provides much of what is known about hospitalizations for motor accidents, measles, methamphetamine, and thousands of other medical issues. Medical errors caused by missed diagnoses, drug errors, hospital infections, and other factors kill and maim tens of thousands of Americans each year.

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