FDA Law Blog

NOVEMBER 6, 2022

2011), here , and United States v. Now, after an unfavorable HHS Office of the Inspector General (OIG) advisory opinion and two defeats in court, Pfizer has appealed the Second Circuit’s decision to the Supreme Court. At the center of Pfizer’s argument is whether an AKS violation requires corrupt intent. Background. 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

NOVEMBER 4, 2024

As background, the Center for Veterinary Medicine (CVM) had approved a regulatory method for carbadox in 1998 but changed its position in 2011. Under that method, the company’s testing demonstrated that no residue of the drug can be found in an edible portion of the animal after slaughter or in any food derived from the living animal.

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The Clinical Problem Solvers

DECEMBER 16, 2020

Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions? 13:16 Status of the current conversation on removing race from eGFR calculators: why is it so contentious? Poet Marge Piercy has written, “The work of the world is as common as mud.”

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FDA Law Blog

SEPTEMBER 11, 2023

In 2011, the Institute of Medicine released a report recommending elimination of the 510(k) process altogether ( link ), noting an inherent conflict between the legislative framework and FDA’s stated goals to protect patients and promote innovation in support of public health.

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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. We have also noticed a renewed emphasis on requirements related to remedial compliance programs in these civil settlements, often including a Memorandum of Agreement (MOA) with DEA and in some cases requiring a third-party auditor. Background.

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FDA Law Blog

JULY 24, 2023

Its main argument is that Congress included only two exceptions to FDA’s restriction barring FDA from granting new approvals during the ODE period: the inability to provide sufficient quantities of a drug and consent from the ODE holder.

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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. By Sophia R. Gaulkin & Riëtte van Laack — On October 31, 2023, the U.S.

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FDA Law Blog

OCTOBER 17, 2021

As part of the process of moving from the old rule-based monograph system to an administrative order framework, the CARES Act provides that in most cases a final monograph or tentative final monograph that establishes conditions of use for a drug described in section 505G(a)(1) or (2) of the FD&C Act is “deemed to be a final order”.

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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. We have also noticed a renewed emphasis on requirements related to remedial compliance programs in these civil settlements, often including a Memorandum of Agreement (MOA) with DEA and in some cases requiring a third-party auditor. Background.

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FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). We do not address the technical and administrative details of the Discount Program here. Final Guidance at 2.

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GeriPal

DECEMBER 15, 2022

Summary Transcript Summary. We’ve talked at length on prior podcasts about the failures of aducnumab, Biogen, and the FDA’s decision to approve it. . But wait, there’s a shiny new anti-amyloid drug, lecanemab! (No No it’s not just the French version of Aducanumab). . In an article in the NEJM (a published article this time, wonder of wonders!)

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Medical Xpress

JUNE 16, 2025

The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Food and Drug Administration (FDA). The process could take years. Ibogaine is made from the root of a plant found in Africa. It has been banned in the U.S. Former Texas Gov.

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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.

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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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GeriPal

DECEMBER 8, 2022

Eric’s blog post on Dignity Therapy from 2011. Summary Transcript Summary. Eric and I weren’t sure what to call this podcast – storytelling and medicine? Narrative medicine? We discussed it with today’s guests Heather Coats, palliative care NP-scientist, and Thor Ringler, poet. Because that really is what this is about. SPONSOR: .

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GeriPal

MARCH 2, 2023

2011-2014 JAMDA 2020 Efficacy of Gabapentinoids: Gabapentinoids for Pain: Potential Unintended Consequences. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications.

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GeriPal

NOVEMBER 2, 2023

I’ve seen this question come up a lot since finishing fellowship nearly two decades ago. Historically, answers generally lamented the ever increasing need for geriatrics without a corresponding growth in the number of specialists in the field. Mike, welcome to GeriPal. Mike: Great to be here. Alex: We’ll take any Warriors we can get.

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GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . It’s been around for a long time but is acting like the hot new kid in town. Just look at this year’s AAHPM meeting, where it felt like every other session was talking about how hot buprenorphine is right now. So here we go.

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GeriPal

APRIL 13, 2023

Check out some of their recent work, including: Dr. Holt-Lunstad’s and Dr. Perissinotto’s powerful perspective piece in the New England Journal of Medicine which provides a clinical framework for addressing loneliness and social isolation. Welcome back, Ashwin. Ashwin Kotwal: Excited to be back. Eric: Now, it’s interesting. All right.

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FDA Law Blog

MAY 11, 2023

Instead, the Government takes the position that, to support an inference of intent to induce infringement, independent evidence that the generic sponsor understood its carved-out labeling to encompass patented uses and proof that petitioner expected and encouraged doctors to rely on the labeling should be necessary.

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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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FDA Law Blog

FEBRUARY 5, 2024

If expanded choices are desirable, FDA recommends following the standards from the 2011 HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status and provides more detailed categories from that guidance. describe the sociocultural construct of our society.”

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FDA Law Blog

JANUARY 23, 2023

The Act provides a lot of detail in what the guidance—and in turn, diversity action plans— should cover. The COVID-19 pandemic temporarily halted many clinical trials and left an indelible mark on clinical trial recruitment. FDA can waive the requirement to submit a diversity action plan on its own initiative or at the request of a sponsor.

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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. Cervical Spine Injuries are fortunately rare in children. this episode is all about learning when to suspect them, how to immobilize the C-spine properly, and which imaging test to choose.

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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. How do you find time to write and also be doctors and academic professors? In all seriousness, you don’t actually have to want to write a book to be interested in this podcast.

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GeriPal

JULY 7, 2022

We discussed the nature of pain, what makes chronic pain different from acute pain, what’s the difference between proprioception, pain, and suffering, and so much more. Haider is a physician at the Brigham and Women’s Hospital, and the VA in Boston. Welcome back to the GeriPal podcast, Haider. It’s just such a pleasure to be back.

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BMJ

JUNE 25, 2021

With landmark analysis, survival can be visualised by plotting the Kaplan-Meier survival curves for the risk groups of interest to provide information about the absolute and relative risks, whereas this is not straightforward for time-dependent Cox regression. and the prediction window at 5 years. 16 Figure 1. Jun JE, Cho IJ, Han K, et al.

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Medical Xpress

JUNE 7, 2025

The content is provided for information purposes only. None of the participants who received the injections got HIV. That early success helped boost Gileads stock by 73% over the past year, The Wall Street Journal reported. "We Explore further Twice-yearly injection cuts HIV risk by 96%, but will cost cut access? What are the consequences?

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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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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. Officials warn of increased risks for the elderly, outdoor workers and those without AC. Your blood pressure may decrease." Youve lost the ability to dissipate heat," he says.

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Physician's Weekly

JUNE 11, 2025

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. MemoryLane Care Services provides the museum employees with training in dementia sensitivity so they can lead tours for the memory cafe participants.

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FDA Law Blog

JUNE 9, 2021

As explained in CPG 440.100 and on FDA’s website , FDA adopted the “Unapproved Drug Initiative” (“UDI”) in 2006—later revised in 2011 —to remove unapproved drugs from the market using a risk-based approach both to ensure the safety and efficacy of all drug products on the market and the integrity of the drug approval process.

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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. Unvaccinated or under vaccinated children are functionally immunocompromised in specific clinical scenarios such as fever without source. So how common is it for children to be unvaccinated in the United States?

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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. House Republicans passed the bill in late May, and it now awaits Senate consideration. That’s closer to 50% now, he said.

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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. We got it just in time.”

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