FDA Law Blog

NOVEMBER 6, 2022

In its petition filed earlier this month, Pfizer challenges HHS’s interpretation of the AKS as “staggeringly overbroad,” contrary to the congressional intent behind the AKS, and a threat to “almost any activity that facilitates patient access to federally funded healthcare.” 2011), here , and United States v. Borrasi, 639 F.3d

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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. In case you do not have time to watch the town hall , we provided a summary of select topics that are discussed below.

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FDA Law Blog

SEPTEMBER 15, 2024

The PREVAIL Act In short, the PREVAIL Act is intended to, among other things, reform the Inter Partes Review (“IPR”) process created by the 2011 Leahy-Smith America Invents Act. This in turn can allow generic and biosimilar companies to launch their products sooner, providing patients with earlier access to more affordable medications.

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FDA Law Blog

FEBRUARY 28, 2024

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. Prior to FDORA’s enactment, the statute did not provide details on the withdrawal procedures other than offering an opportunity for an informal hearing.

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FDA Law Blog

JULY 24, 2023

Specifically, FDA determined that Avadel’s Lumryz can “break” Jazz’s ODE because it is “clinically superior” based on Lumryz’s “major contribution to patient care,” rendering it not “the same drug” under the Orphan Drug Act.

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FDA Law Blog

NOVEMBER 9, 2023

The FDA Food Safety Modernization Act (FSMA) enacted in 2011, aims to ensure the U.S. However, currently, prior notice of food articles arriving by international mail requires the notifier to provide to FDA only with the anticipated date of mailing. This information is insufficient to allow FDA to predict when a shipment will arrive.

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FDA Law Blog

MAY 3, 2021

Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. 39,318 , 39,324 (July 6, 2011). 6 (2011) (statement of Michele M. They are not authorized to inspect financial data, sales data other than shipment and transaction data, or pricing data unless the registrant provides written consent.

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FDA Law Blog

OCTOBER 17, 2021

Livornese — Many of us have been waiting not-so patiently for FDA to begin implementing the over-the-counter (OTC) monograph reform provisions of the 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (see our blog post here ). nighttime sleep aid drug products), the repository provides an OTC Monograph ID (e.g.,

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FDA Law Blog

MAY 3, 2021

Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. 39,318 , 39,324 (July 6, 2011). 6 (2011) (statement of Michele M. They are not authorized to inspect financial data, sales data other than shipment and transaction data, or pricing data unless the registrant provides written consent.

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Medical Xpress

JUNE 16, 2025

DOI: 10.1038/s41467-025-58661-1 Journal information: Nature Communications Provided by National Taiwan University Citation : Rewiring the body clock: Deep brain imaging reveals unexpected complexity in jet lag adjustment (2025, June 16) retrieved 16 June 2025 from [link] This document is subject to copyright. Your feedback is important to us.

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Medical Xpress

JUNE 16, 2025

The content is provided for information purposes only. Citation : Texas invests $50M in psychedelic drug research to treat addiction (2025, June 16) retrieved 16 June 2025 from [link] This document is subject to copyright. Your feedback is important to us. However, we do not guarantee individual replies due to the high volume of messages.

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GeriPal

JANUARY 16, 2025

So I think the first reason that we saw and felt the opportunity was ripe for updating was that some of us had come across some anecdotal examples of patients expressing some offense to that terminology. And I was asking this patient about if he had filled out an advanced directive. Is the patient in your descriptor?

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GeriPal

DECEMBER 8, 2022

Clinicians “catching” patient life stories. . Our patients aren’t “the 76 year old with heart failure in room 202,” as Heather Coats astutely noted. Storytelling Helps Hospital Staff Discover The Person Within The Patient. Eric’s blog post on Dignity Therapy from 2011. Because that really is what this is about.

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GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. There are a lot of reasons that may explain the massive increase in use of these drugs.

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GeriPal

DECEMBER 15, 2022

Along the way we address: Is this degree of slowed cognitive decline meaningful to patients or care partners? Eric: So patient narrative storytelling, independent of what we call it, I’d like to turn to both of you and just how you got interested in this as a subject. She was a heart failure patient.

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GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . And I remember being there and there was a patient who had seen inpatient and then subsequently outpatient who was so thankful in the weirdest in just this irrational way for having been diagnosed with liver cancer.

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GeriPal

APRIL 13, 2023

But, should we as clinicians care about the social lives of our patients? Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? Has kept me interested, the patient experience and the older adults in the community, their experience.

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GeriPal

NOVEMBER 2, 2023

Ryan: I started in 2011. Eric: How does it feel like for you, Ryan, since 2011, you’ve had different roles? And one of the things was, “You’re telling us stuff we already know”, and also, “I’m going to critique you in that you didn’t provide any solutions.” How long ago?

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PEMBlog

JUNE 5, 2024

Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. 2011 Aug;58(2):145-55. The most common injuries seen in these younger patients are growth plate fractures and ligamentous injuries. MMWR Recomm Rep. 2012 Jan 13;61(RR-1):1-20. PMID: 22237112. Ann Emerg Med.

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Medical Xpress

JUNE 8, 2025

While many of these procedures provide critical care, we know they are acutely painful. Provided by The Conversation This article is republished from The Conversation under a Creative Commons license. The content is provided for information purposes only. During this time, they receive up to 16 painful procedures every day.

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GeriPal

MARCH 16, 2023

So this week we’re going to be talking about writing for the lay public, and next week we’ll be publishing a podcast on writing for healthcare providers. Rosanne: I think I was motivated by the number of times patients asked me to get rid of their pot-bellies, quite honestly. Rosanne: I certainly do. ” Or something.

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BMJ

JUNE 25, 2021

9 The availability of electronic health records makes it easier to follow up on patients’ health information for an extended period. In clinical practice, patients are not fixed on a certain treatment regime and can start and stop at any time. and the prediction window at 5 years. 16 Figure 1. 2016;11(11):e0166847. Atherosclerosis.

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GeriPal

JULY 7, 2022

And then once I came to the United States, I saw this whole different dimension of pain, because I started residency in 2011, this was really at the peak of the opioid prescription epidemic, if you may. One of the patients I spoke to really said this quite well. And yet very, very few patients are actually using those services.

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Medical Xpress

JUNE 7, 2025

The content is provided for information purposes only. Citation : Long-lasting HIV prevention shot headed toward approval (2025, June 7) retrieved 9 June 2025 from [link] This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission.

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Medical Xpress

JUNE 8, 2025

million surfs carried out each year in Victoria, researchers estimate that this could equate to more than 70,000 assists and almost 25,500 cases of first-aid provided by surfers annually. This is the first study to quantify surfer beach -safety actions, providing real-world implications of their impact. With more than 6.3

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Physician's Weekly

JUNE 11, 2025

And that support is for the patient and their caregiver — because both can experience social isolation and distress after a diagnosis. A 2021 study published in Frontiers in Public Health indicated that even online memory cafes during the pandemic provided social support for both patients and their family members.

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Medical Xpress

JUNE 23, 2025

Enzymes provide the body with instructions for what it needs to do, and when people lose energy and water, biochemical systems in the body start to fail, Wood says. Provided by Northeastern University This story is republished courtesy of Northeastern Global News news.northeastern.edu. Similarly, you need to have energy.

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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. of their patients were fully vaccinated, five and a half percent were under vaccinated, and 3% were unvaccinated. As long as the patient doesn’t have any risk of endocarditis, any other bug that grows.

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Physician's Weekly

JUNE 13, 2025

Also, the bill would curtail taxes that nearly every state levies on providers to help draw down billions in additional federal money, which generally leads to more money for hospitals. But about half of rural hospitals are still independent, Topchik said, and struggle with a perennial collision of low patient volume and high fixed costs.

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Physicians News Digest

APRIL 1, 2025

Since returning to the White House, Trump has said he will target fraud in Medicare, Medicaid, and Social Security, and his Republican allies in Congress have made combating fraud a key argument in their plans to slash spending on Medicaid, which provides health care for millions of low-income and disabled Americans.

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