PEMBlog

MAY 31, 2023

When we think of managing agitated patients we think of medicines – but that shouldn’t be our first option. Government. 2023 Mar 21:S1876-2859(23)00091-8. Qualitative study of patient experiences and care observations during agitation events in the emergency department: implications for systems-based practice.

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FDA Law Blog

OCTOBER 8, 2023

Palmer — On Friday, October 6, 2023, DEA announced a second extension of telemedicine flexibilities concerning the prescribing of controlled substances, which were originally set to expire after the end of the COVID-19 pandemic emergency. By Karla L. comments on the two proposed rules.

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FDA Law Blog

FEBRUARY 27, 2025

While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3). The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.

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PEMBlog

JUNE 14, 2023

Government. Pediatrics March 2023; 151 (3): e2022057383. Boarding of Mentally Ill Patients in Emergency Departments: American Psychiatric Association Resource Document. Characteristics, Clinical Care, and Disposition Barriers for Mental Health Patients Boarding in the Emergency Department. Nash, Kavita Parikh, Bonnie T.

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PEMBlog

MAY 17, 2023

Furthermore, the connection between physical and functional symptoms is inextricably linked in many patients. Government. Diagnostic yield of head CT in pediatric emergency department patients with acute psychosis or hallucinations. Why then do we persist with the “is it medical/organic or psych” question?

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FDA Law Blog

MAY 19, 2025

86, 72703 (December 22, 2021), DEA emphasized in the Gulf Med decision that prescribing [r]ed flags are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm. Patients filling prescriptions at the same time at multiple pharmacies. 81, 86, 251.

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FDA Law Blog

JUNE 3, 2024

Wasserstein — Today’s email brings an interesting, and somewhat confusing settlement of what should have been an ordinary antikickback statute case , and may bring about a clash between what many companies do and what the government may be objecting to. In 2023, DePuy paid $9.75 The facts of the settlement are rather simple.

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FDA Law Blog

JULY 17, 2022

An example of such a drug is a single-use vial of an injectable cancer drug that is dosed based upon weight, and therefore might not be entirely used for a lighter weight patient. On July 8, as part of its annual physician fee schedule update for 2023, CMS issued a proposed regulation to implement the new refund.

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FDA Law Blog

MARCH 1, 2023

Brevig, Senior Regulatory Device and Biologics Expert — In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system. By Holly N.

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FDA Law Blog

MAY 30, 2024

In 2010, the Health Resources and Services Administration (HRSA) authorized covered entities to contract with an unlimited number of retail pharmacies to fill prescriptions for their patients. District Court and won, prompting a government appeal to the D.C. Novartis and United Therapeutics Corporation sued in the D.C.

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FDA Law Blog

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. More updates will follow here as trends develop in 2023. Combination products might be part drug, part device, or part software or hardware.

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FDA Law Blog

MARCH 24, 2024

The 340B statute is silent about delivery and distribution of pharmaceuticals by pharmacies to patients even though pharmacies are essential and a legally required part of the drug distribution chain. They merely dispense 340B drug to the patients of covered entities, while covered entities purchase and maintain title to the drugs.

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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. 72,694, 72,703 (Dec.

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FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

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FDA Law Blog

MARCH 30, 2022

Earlier this week, FDA issued its Fiscal Year 2023 Budget Justification and related documents. Among the various documents, a document titled “ Executive Summary of FY 2023 Legislative Proposals ” caught our attention.

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ABIM

MAY 30, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. Community Practice in ABIM Governance* Erica N.

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FDA Law Blog

SEPTEMBER 12, 2023

The risks to hospitals and pharmacies are multi-faceted and growing.

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Medical Xpress

JUNE 16, 2025

This region governs essential behaviors like the circadian clock, sleep, energy balance , and feeding. Po-Ting Yeh, the studys first author, explains the challenge: "It is difficult to study the basic physiological functions controlled by the hypothalamus, which lies deep inside the brain.

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FDA Law Blog

SEPTEMBER 26, 2023

The risks to hospitals and pharmacies are multi-faceted and growing.

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PEMBlog

MAY 24, 2023

Patient that are agitated should always be treated with dignity and respect. Government. Structured team approach to the agitated patient in the emergency department. This entails utilizing the least invasive non-pharmacologic means of assisting them, before moving to physical or chemical restraints. Emerg Med Clin North Am.

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GeriPal

SEPTEMBER 5, 2024

And Bill Andereck is still haunted by the decision he made to have the police break down the door to rescue his patient who attempted suicide in the 1980s, as detailed in this essay in the Cambridge Quarterly of HealthCare Ethics. The patient case. I think the theme is more saving someone’s life and the regret that follows.

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FDA Law Blog

APRIL 8, 2024

What about government factors that cause drug shortages? pharmacy benefit managers (PBMs), group purchasing organizations (GPOs), wholesale distributors) play before a finished product ever makes it to a patient. Finally, on October 3, 2023, DEA published an increase to the methylphenidate APQ. surgical robots, MRIs)?

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FDA Law Blog

NOVEMBER 21, 2024

DEA notes in the Federal Register notice that it received over 38,000 comments to its 2023 proposed rules (35,454 for the general telemedicine flexibilities proposed rule and 2,915 for the buprenorphine telemedicine flexibilities proposed rule), and held two days of public listening sessions addressing industry comments.

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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. And that’s an ADC of two to three patients a day. JAMA Health Forum.

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FDA Law Blog

OCTOBER 17, 2023

This 2022 draft guidance proposed that certain non-addictive medical products for pain or addiction treatment could be eligible for breakthrough designation, aligning with the Agency’s obligations under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.

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GeriPal

SEPTEMBER 29, 2022

Janet Abrahm is one of the world’s experts in pain and symptom management for patients with cancer joins us to talk about (among other things): Ketamine for hyperalgesia and allodynia, how to treat dissociative side effects. Eric and I are working on it…maybe by 2023? . For me it’s radiation induced mucositis/esophagitis.

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FDA Law Blog

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. These, at least, are deserving of comments, which are due by July 25, 2023.

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GeriPal

MARCH 6, 2025

So we did a podcast on aging and homelessness with Margot Kushel in 2023. And I wonder if that is key in patients, people who are experiencing homelessness as well. Government is not the 51st state. Naheed 00:31 Thanks so much for having me here. Really looking forward to the conversation. Eric 00:34 I’m excited for this.

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FDA Law Blog

AUGUST 14, 2022

Inflation rebates under Medicare Parts B and D: Starting in 1Q 2023, mandatory quarterly rebates will be imposed on manufacturers of single-source drugs and biologics covered under Part B that have price increases exceeding the rate of inflation. The same will be required under state Medicaid and CHIP programs by October 1, 2023.

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FDA Law Blog

FEBRUARY 11, 2024

We blogged on the December 5, 2023, letter from six Democratic governors to President Biden). The regulated cannabis marketplace brings in billions of dollars in revenue into state and federal governments, with predictions that cannabis sales will exceed $53 billion by 2027. Letter to U.S.

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GeriPal

AUGUST 15, 2024

Ongoing reports from patients about anti-Asian hate experiences Should clinicians screen for Anti-Asian hate? This question, while providing an opportunity to talk about direct and indirect experiences, can be asked of all patients, and opens the door to conversations about anti-semitism, islamophobia, or anti-Black racism.

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GeriPal

APRIL 20, 2023

Today we talk with Margot Kushel about how we got here, including: That sense of powerlessness as a clinician when you “fix up” a patient in the hospital, only to discharge them to the street knowing things will fall apart. It was in the mid-nineties, and about half of the patients that we cared for in the inpatient service were homeless.

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GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Care Ecosystem.

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Common Sense Family Doctor

APRIL 25, 2025

While I'm grateful for subspecialists who alleviate pain, rescue patients who are unable to breathe on their own, manage complicated fractures, and replace worn-out hips and knees, the gap between the number of family doctors we need and the number we have keeps getting wider. This is where the federal government must step up.

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FDA Law Blog

AUGUST 3, 2021

Department of Health and Human Services in December 2020 to prevent Medicare Part D and Medicaid Managed Care plans from receiving rebates from manufacturers unless the rebates are passed through to pharmacies to reduce patient out-of-pocket expenses. We previously explained the rebate rule and its likely impact on patients and payors here.

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Physician's Weekly

JUNE 26, 2025

He directed the patients to seek local help. While it’s possible that Nath’s patients suffered covid vaccine injuries, Marks said, their symptoms were so varied it was hard to characterize a possible syndrome. His clinical study was ending. But, Dressen said, there wasn’t any. Kennedy Jr. forced him out in May.

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FDA Law Blog

SEPTEMBER 14, 2021

This bill, which addresses numerous areas of the economy, public health, and government regulation, includes Subtitle E, Drug Pricing. Under all of these programs, patient co-insurance would be calculated based on the MFP so that patients receive the benefit of that price. Subtitle E is a slightly modified version of H.R.

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