My Green Doctor

APRIL 4, 2025

According to the 2023 report of the Lancet Countdown, mortality caused by extreme heat events increased by 53.7% My Green Doctor offers customized consulting and guidance—reach out to us! Contact us at hmassey@mygreendoctor.org to set up a FREE consultation on making your clinic more sustainable. Need help planning an event?

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FDA Law Blog

DECEMBER 7, 2023

A regulatory consultant on the panel made a recommendation to FDA that it lean more heavily on Remote Interactive Evaluations (“REIs”) to help alleviate its backlog—of which HPM recently learned the Agency had only conducted 10 in the last 30 months for purposes of drug manufacturing compliance.

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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

JULY 31, 2023

Now, in July 2023, DEA has finally issued its final rule amending its regulations for partial filling of prescriptions for schedule II substances. 46,983 (July 21, 2023). Partial Filling of Prescriptions for Schedule II Controlled Substances, 85 Fed. 78,282 (Dec. codified at 21 C.F.R. b)(5)(ii)).

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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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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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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. The Meckel’s scan is the preferred diagnostic modality, and prompt surgical consultation may be necessary for symptomatic cases.

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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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Today's Hospitalist

MAY 9, 2025

Looking ahead, here are several emerging innovations that promise to shape the next generation of these tools: Deeper integration with hospitalist workflow: Initiating an AI-assisted note may soon be as effortless as speaking naturally during a patient consult—no disruptions, no clicks. Published July 26, 2023. MEDITECH News.

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FDA Law Blog

JANUARY 29, 2023

The analysis shows, predictably, that FDA inspections of drug manufacturing facilities dropped precipitously during the first two years of COVID, but are gradually ramping up again, consistent with FDA’s predictions (see August 2022 blogpost linked here ). FDA, Inspections Database (last visited Jan. Legal Assistant/Paralegal

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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

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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The Clinical Problem Solvers

APRIL 24, 2025

Additionally, he consults with federal agencies on mental health system design and practices. Dr.  2023 Apr;21(2):166-7. Clinically, he cares for youth and families through the Department of Psychiatry & Behavioral Sciences and the new Division of Addiction Medicine at Boston Children’s Hospital. 2022;31(2):211-221. 2022.01.002 4.

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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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IT Consulting Manufacturing Provider 52

The Medical Futurist

MAY 18, 2025

With Teladoc , Doctor on Demand , Health Tap , or American Well patients in remote areas have access to high-quality emergency consultations for stroke, cardiovascular, dermatological problems, or any other complaints. Exoskeletons started finding their place in healthcare systems.

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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

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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Family Physicians of Greeley

MAY 17, 2023

If you struggle with sleep difficulties, consider implementing relaxation techniques or consulting with a healthcare professional. Create a relaxing bedtime routine, avoid screens before bed, and ensure your sleeping environment is comfortable and conducive to restful sleep.

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FDA Law Blog

FEBRUARY 23, 2025

For example, in an October 13, 2023 WL to ReNovo, Inc., Thus, when evaluating your next set of device changes and whether a new 510(k) is needed, you may want to consult a third-party database (or an advisor that has access to such a database) to help with this search.

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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–. After one day he was transitioned to oral levofloxacin and clindamycin to complete a 2-week antibiotic course.

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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.

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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.

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Medical Patients Healthcare Electronics 45

PEMBlog

OCTOBER 18, 2024

Always review the latest care plans, assess longitudinal trends in cardiac biomarkers, and consult with specialists when needed to ensure that each patient receives individualized and optimal care. Updated 2023 Jul 10]. Cardiac Management of the Patient With Duchenne Muscular Dystrophy. Pediatrics. 2018 Oct;142(Suppl 2):S72-S81.

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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. After his participation in the first hybrid meeting at CDER on March 28, 2023, Sasinowski remarked that the interaction between the FDA and sponsors felt more close-knit, resulting in a more intimate meeting atmosphere.

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Screening Transportation Provider Electronics 59

FDA Law Blog

JANUARY 30, 2025

In its new guidances, FDA advises that sponsors should consult with the Agency regarding confirmatory trial design and conduct as early as possible with enough time to allow the trial to be underway at the time of approval. However, the meaning of due diligence has long been a question.

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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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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 J Emerg Med. 2014;46(6):800-807 Santiago LI, Tunik MG, Foltin GL, Mojica MA. Implementation of a Medical Clearance Algorithm for Psychiatric Emergency Patients.

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FDA Law Blog

FEBRUARY 1, 2022

Further, the Report notes that a GAO Report on the Orange Book due to Congress in 2023 “may help inform the Agency’s thinking” on Orange Book issues, which suggests that we should not expect any changes or clarifications in the near future. The Agency however has made no commitments—nor has it even hinted at—revising the Orange Book.

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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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Patient-Centered Clinic Patients Provider 49

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.

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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. 823(g)(1).

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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). AlexSmithMD 1. Beth, welcome to GeriPal. Beth: Thank you. Greg, welcome to GeriPal.

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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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PEMBlog

OCTOBER 19, 2023

Additional labs ordered per the consultant’s recommendations were notable for elevated PT/PTT, AFP, plasma tyrosine, and urine succinylacetone consistent with a diagnosis of tyrosinemia. Seattle (WA): University of Washington, Seattle; 1993-2023. However this biopsy revealed evidence of fibrosis and no concern for malignancy.

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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 The SELECT trial , which was published in the NEJM in November 2023, tested semaglutide vs. placebo. Ackermann explained.

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Doctor On Demand

APRIL 28, 2025

A short-term sore throat may resolve on its own — monitor symptoms or consult a primary care doctor. Frequent sore throats aren’t always a sign of a serious condition, but it’s worth consulting a doctor to identify the cause. Prolonged sore throats may indicate a bacterial infection or another medical issue.

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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. Bea Bosco is our consulting director of operations. And our new intern: Welcome Lauren Gould! It was edited by Ellen Weiss. Adam Raymonda is our audio wizard.

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