Today's Hospitalist

MAY 9, 2025

We have seen explosive growth and become a cornerstone of modern health care systems. Yet this expansion has come with a significant administrative burden, particularly that of clinical documentation. Documentation isn’t just time-consuming; it also contributes to pervasive physician burnout. It’s about augmenting your capabilities.

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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. This case followed. The Court held that it does.

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FDA Law Blog

JUNE 28, 2023

Using an ASCA-accredited testing laboratory to produces test results using the ASCA template may reduce the need for a lead reviewer to request consultations on a submission and reduce the size of the report submitted, thereby saving time on during the premarket review.

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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

FEBRUARY 21, 2024

1842 ) (Innovative FEED Act), introduced in 2023, would amend the FDC Act to provide CVM with the required authority. By Riëtte van Laack — On Feb. 2, 2024, FDA’s Center for Veterinary Medicine (CVM) announced that it will withdraw its Program Policy and Procedures Manual Guide 1240.3605 (PPM). That remains to be seen. 6687 and S.

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PEMBlog

OCTOBER 26, 2023

STAT Pearls, 2023 Wrap Up Meckel diverticulum is a congenital anomaly of the small intestine that can present with various clinical manifestations, including rectal bleeding and obstruction. It arises from incomplete involution of the vitelline duct during embryonic development, typically occurring by the 7th week of gestation.

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FDA Law Blog

NOVEMBER 30, 2023

The 2023 Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation and Compliance Conference will boast two speakers from Hyman, Phelps & McNamara, P.C. (“HPM”), next week, on December 6-7, 2023. HPM”), as well as other experts from FDA, DOJ, and the private sector.

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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

APRIL 22, 2024

We blogged in February about the October 2023 letter from former DEA Administrators, Ms. Democratic senators also weighed in, supporting rescheduling to schedule III in December 2023. Whether DEA is consulting the Department of State about treaty obligations regarding marijuana and diplomatic implications of rescheduling?

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FDA Law Blog

JANUARY 29, 2023

Evans* — A recent analysis of statistics on FDA’s website, prepared for a presentation at a good manufacturing practices (GMP) conference in San Diego next week, shows a dramatic increase in the percentage of FDA drug manufacturing facility inspections that result in an “Official Action Indicated” classification. Legal Assistant/Paralegal

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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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Family Physicians of Greeley

MAY 17, 2023

If you struggle with sleep difficulties, consider implementing relaxation techniques or consulting with a healthcare professional. Maintaining good mental health is essential for our overall well-being. In this blog, we will explore effective strategies for improving mental health and nurturing a positive mindset.

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FDA Law Blog

FEBRUARY 23, 2025

For example, in an October 13, 2023 WL to ReNovo, Inc., Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. But this guidance has its limitations.

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GeriPal

NOVEMBER 9, 2023

Hot off the presses RCT in JAMA October 2023: Study that looks at 1000 female resident physicians at 26 sites that showed that coaching improved each outcome assessed (burnout, moral injury, imposter syndrome, self-compassion, and flourishing). [link] 2. Summary Transcript Summary Coaching is in. We address: What is coaching? AlexSmithMD 1.

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FDA Law Blog

AUGUST 21, 2023

16, 2023 ( DOJ Press Release ). In the unlikely event a regulated seller cannot recall whether they have self-certified, they can consult DEA’s monthly self-certification list of all who have current self-certifications found at the Diversion Control Division CMEA Monthly List. We note that in December 2020, the same U.S.

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FDA Law Blog

SEPTEMBER 17, 2023

citizens, including green card holders, must follow additional steps, so consult with your lead reviewer for guidance. During this time, CDRH moved from Webex to Zoom and gained experience with the virtual platform. Having a hard copy of this email may expedite your entry through security checkpoints. Be ready with backup options (e.g.,

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PEMBlog

SEPTEMBER 24, 2024

Pulmonology and surgery were consulted during his hospital stay, and he has since had a left lower lobectomy after healing from his pneumonia. 2023 Jul 24. Treasure Island (FL): StatPearls Publishing; 2023 Jan–. The CT also showed normal pulmonary venous return via the left lower pulmonary vein. Clin Perinatol. 2022.08.003.

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FDA Law Blog

FEBRUARY 1, 2022

To that end, FDA announced that it would take the public input it has received and form a working group to address efforts to “modernize the Orange Book, improve transparency, and provide useful information to regulated industry and the public” by…considering the comments that it has supposed to have been considering all along.

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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., For those who are interested in learning more about the decentralized clinical trial draft guidance, please check out the FDA’s webinar on June 20, 2023. By Philip Won & McKenzie E.

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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. We suggest consulting the draft guidance for a few representative examples of situations in which FDA may recommend animal testing.

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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. Sponsors may consult with the Agency to release out of specification product if a patient is at significant risk and is conditioned to receive the product. before evaluating clinical effectiveness).

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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. Tobolowsky & David B.

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PEMBlog

SEPTEMBER 6, 2023

Children requiring psychiatric consultation in the pediatric emergency Berg JS, Payne AS, Wayra T, Morrison S, Patel SJ. Hosp Pediatr (2023) 13 (1): 66–71 When should the emergency physician obtain lab tests to medically clear such patients? Decades ago, psychiatric complaints in the pediatric ED were infrequent. J Emerg Med.

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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. By Larry K. 823(g)(1).

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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. Five states have granted NPs full practice authority since 2021, with Utah the most recent state to remove physician supervision requirements , in 2023. “Hello.

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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. So, this year, “An Arm and a Leg” asked listeners: What strategies have you used when you’ve been struck by pharmacy sticker shock? He left without it.

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Today's Hospitalist

JUNE 7, 2025

In guidance released in 2023, the American Society of Anesthesiologists recommended holding a dose on the day of surgery for those taking a daily dose—and a week prior for those on weekly dosing. (If Nor should they be. “I would not recommend starting a GLP-1 in the hospital.” “We really don’t yet know.”

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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. JAMA IM 2021 Hospice Acquisitions by Profit-Driven Private Equity Firms. JAMA Health Forum.

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Doctor On Demand

APRIL 28, 2025

Listen to a discussion on getting help for a sore throat When to go to urgent care for a sore throat Go to urgent care if your sore throat is severe, lasts more than five days or comes with other symptoms like a high fever, swollen lymph nodes, or you have difficulty swallowing. This is a medical emergency where you should call 911.

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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. It’s there.

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GeriPal

JANUARY 16, 2025

We’re going to be talking about the American Geriatric Society position statement on making medical treatment decisions. Alex 02:21 For Eric 02:21 For unrepresented older adults. But before we go into that topic, Tim, I think you have a song request. Tim 02:29 Yeah, it’s such an honor to make a song request. Can you guys do that one?

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PEMBlog

MARCH 27, 2024

Updated 2023 Jul 17]. This episode will help you better prepare for and manage children with inborn errors of metabolism in the Emergency Department. Consider it a supplement to what you remember from Biochemistry and the instructions on the family’s laminated care plan sheet. References Jeanmonod R, Asuka E, Jeanmonod D.

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FDA Law Blog

JUNE 26, 2023

39,479, (June 16, 2023). In determining updates to the Special Surveillance List, DEA consulted multiple levels of law enforcement, forensic laboratory authorities, intelligence groups, drug profiling programs and international organizations. 21 U.S.C. § DEA’s notice of proposed updates is available here.

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GeriPal

MARCH 6, 2025

So we did a podcast on aging and homelessness with Margot Kushel in 2023. Today we discuss: What is the best terminology? Homelessness? Marginally housed? What makes palliative care for people experiencing homelessness challenging? What makes it rewarding? Naheed 00:31 Thanks so much for having me here. Eric 00:34 I’m excited for this.

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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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PEMBlog

JANUARY 16, 2025

Clin Toxicol (Phila) 2023; 61:453. Updated February 26, 2024. Accessed January 13, 2025. link] Hogge RL, Spiller HA, Kistamgari S, et al. Inhalant misuse reported to Americas Poison Centers, 2001-2021. The next drug epidemic is blue raspberry flavored: How Galaxy Gas became synonymous with the countrys burgeoning addiction to gas.

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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. FDA encourages sponsors to consult patients and healthcare providers to assist in developing such strategies. population demographics. population demographics.

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