Today's Hospitalist

MAY 9, 2025

Since the mid-1990s, our capacity for innovation has never stopped as hospitalists navigate a complex landscape of acute illnesses, interprofessional collaborations and the imperative to provide efficient, high-quality care. It offers us a path toward reclaiming our time, reducing burnout and ultimately enhancing the care we provide.

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The Clinical Problem Solvers

MARCH 14, 2025

Additionally, he consults with federal agencies on mental health system design and practices. Dr.  There are a growing number of Child Psychiatric Access Programs, including one in Massachusetts, which provide quick access to psychiatric consultation and facilitates referrals for accessing ongoing behavioral health care.

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FDA Law Blog

SEPTEMBER 20, 2021

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

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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released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. Fiscal Year 2023 showed similar performance.

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FDA Law Blog

NOVEMBER 7, 2024

According to the latest MDUFA performance report , only 25% of 513(g)s in fiscal year 2023 met the 60-day statutory time frame. If a company and/or their regulatory consultant(s)/counsel have evaluated the product and determined it is not a device, the company can decide to proceed to market the product without contacting FDA.

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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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The Medical Futurist

MAY 18, 2025

A human-sized, smiling robot combines the very best in cutting-edge technology and human touch to provide frequent check-ins and non-medical care for residents in long-term care settings. And we could go on and on with the examples of social robots involved in elderly care. Exoskeletons started finding their place in healthcare systems.

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The Clinical Problem Solvers

APRIL 24, 2025

Additionally, he consults with federal agencies on mental health system design and practices. Dr.  The episode also explores how digital tools can help youth manage their mental health, while also noting the need for culturally relevant care providers. 2023 Apr;21(2):166-7. 2022;31(2):211-221. doi:10.1016/j.chc.2022.01.002

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FDA Law Blog

JUNE 28, 2023

As part of that effort, Accreditation Scheme for Conformity Assessment (ASCA) is designed to reduce FDA review time, reduce and/or remove Sponsor guesswork on documentation to provide in a premarket submission, and improve the quality of testing conducted.

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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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Family Physicians of Greeley

MAY 17, 2023

If you struggle with sleep difficulties, consider implementing relaxation techniques or consulting with a healthcare professional. Surround yourself with supportive and positive individuals who uplift you and provide a sense of belonging.

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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 21, 2024

1842 ) (Innovative FEED Act), introduced in 2023, would amend the FDC Act to provide CVM with the required authority. In the absence of the policy, there seems a chance that CVM will recognize that certain claims such as production claims are not drug claims. 6687 and S.

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FDA Law Blog

AUGUST 21, 2023

16, 2023 ( DOJ Press Release ). Regulated sellers must train employees on SCLP sales requirement content developed by DEA and listed on the DEA website provided at the Diversion Control Division Retail Training Page. Austin Pharmacy to Pay $200,000 in Civil Penalties for Alleged Violations of the Controlled Substances Act, Aug.

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FDA Law Blog

SEPTEMBER 17, 2023

Once your request for an in-person or hybrid meeting is agreed upon, you are expected to provide a list of in-person and virtual attendees. 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

JUNE 21, 2023

enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g.,

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FDA Law Blog

FEBRUARY 1, 2022

But that Report was a bit of a letdown, as FDA explained that “the comments received provided a variety of different and sometimes competing views” and thus the Agency would not yet take any action. Let’s take a step back. But none of those “competing views” were novel or unexpected.

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PEMBlog

OCTOBER 18, 2024

Emergency Care Plans and Advanced Directives Many DMD patients will arrive with comprehensive emergency care plans or letters from their providers. Updated 2023 Jul 10]. DMD patients often receive yearly MRIs to monitor their cardiac health, as discrepancies between MRI and echo findings are common. Pediatrics. doi: 10.1542/peds.2018-0333I.

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FDA Law Blog

OCTOBER 10, 2023

In the case of 510(k) Implants indicated for use in pediatric patients, FDA recommends consulting two other guidance documents: Pediatrics Guidance and Extrapolation Guidance. If a submitter believes that certain testing described in the draft guidance does not apply to their device, they should provide a rationale in the 510(k) submission.

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FDA Law Blog

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023.

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PEMBlog

SEPTEMBER 6, 2023

They carry existing diagnoses and are followed by outpatient mental health providers. Attention to any toxidromes, any abnormal vital signs or mental status, eye findings, and neurologic examination provide the greatest help in narrowing the differential diagnosis. Hosp Pediatr (2023) 13 (1): 66–71 J Emerg Med.

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FDA Law Blog

APRIL 23, 2023

The Draft Guidance states that sponsors should consult with the review division early in development about whether an externally controlled trial is reasonable, and they should submit their SAP with the protocol before initiating enrollment. This is potentially discouraging to sponsors of drugs intended for rare and serious diseases.

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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. §

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Physician's Weekly

JUNE 19, 2025

On a gloomy Friday in January, Johnson, a nurse practitioner who treats older adults, had a hospice consult with Ellen, a patient in her 90s in declining health. “We step into places where other providers may not, and geriatrics is a prime example of that.” “Hello. How are you feeling?”

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Doctor On Demand

APRIL 28, 2025

Urgent care clinics provide quick diagnoses and treatments, including antibiotics if needed. When to use telehealth for a sore throat Telehealth offers a convenient way to treat a sore throat and also provides guidance when you’re unsure if you need in-person care. This requires emergency treatment.

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FDA Law Blog

JUNE 26, 2023

The Comprehensive Methamphetamine Control Act of 1996 (“MCA”) amended the Controlled Substances Act (“CSA”) by providing for the Attorney General to publish a Special Surveillance List of chemicals and other “laboratory supplies” used in the clandestine manufacture of controlled substances. 39,479, (June 16, 2023). 21 U.S.C. §

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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. As always, DEFINITELY please let us know how the stuff we provide can be even better. Bea Bosco is our consulting director of operations.

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GeriPal

JANUARY 16, 2025

But you worry that the advance directive does not provide enough guidance for the specific decision at Yael Jo, do you. So it defines unrepresented as someone who lacks decisional capacity to provide informed consent to a particular medical treatment. It doesn’t provide enough guidance for the clinicians to make decisions.

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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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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].

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FDA Law Blog

JUNE 14, 2023

This is about reducing the time and cost and increasing the predictability of going from concept to commercialization.” – Dr. Jeff Shuren During a presentation at the May 17, 2023 Food and Drug Law Institute (FDLI) Annual Conference, CDRH Director, Dr. Jeff Shuren discussed TAP with enthusiasm.

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FDA Law Blog

JULY 9, 2024

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. DAP Goal Rationales The sponsor must also provide a rationale for the study’s proposed enrollment goals, including information and analysis to explain how these goals were determined.

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GeriPal

MARCH 6, 2025

link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. So we did a podcast on aging and homelessness with Margot Kushel in 2023. They can’t believe it, but we come back again and again and again gently to provide that support. We just hired a nurse.

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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.

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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. I would consult a toxicologist because I know that this is rare. Updated February 26, 2024. Accessed January 13, 2025.

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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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FDA Law Blog

AUGUST 21, 2023

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.) Women taking pain medicines who are considering becoming pregnant should also consult with their health care professionals to discuss the risks and benefits of pain medicine use.

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