FDA Law Blog

JANUARY 26, 2022

In defending the complete broadcast, Lilly called out similar elements from each of the individual components as demonstrating its intent to have all three viewed sequentially. By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming!

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FDA Law Blog

OCTOBER 5, 2022

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. The term healthy, as an implied nutrient claim, was first defined by FDA in 1994.

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FDA Law Blog

JUNE 29, 2022

The Expedited Programs Guidance describes situations warranting rescission as when emerging data no longer support the BTD, another product gains traditional approval and evidence is not provided that the designated drug may demonstrate substantial approval over the approved product, or when the program is no longer being pursued.

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FDA Law Blog

FEBRUARY 27, 2024

For years after the enactment of the Hatch-Waxman Amendments the PTO interpreted the PTE statute to permit multiple PTEs, provided there are separate, but not necessarily different, regulatory review periods. FDA-2015-E-2602, FDA-2015-E-2604, FDA-2015-E-2619, and FDA-2015-E-2615. 351, 355-56 (1985).

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FDA Law Blog

JUNE 23, 2021

For example, we know that cancer patients have a high tolerance for toxicity when offered a chance at improved survival, a risk tolerance that would not be shared by individuals suffering from the common cold. the morbidity, oftentimes irreversible and progressive, and morality associated with their condition).

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FDA Law Blog

JANUARY 31, 2022

In addition, the Complaint alleges inappropriate dispensing to numerous individuals, multiple DEA recordkeeping violations, improper alteration of prescriptions, and violations Texas law and federal corresponding responsibility obligations required of pharmacists that dispense opioid prescriptions. 21 U.S.C. § Complaint ¶ 38.)

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GeriPal

JUNE 19, 2025

Noelle Marie 01:24 I think it really speaks a lot to my own personal journey and I’m pretty sure a lot of trans and gender diverse individuals also resonate with and it really speaks about our transition, celebrating our authentic selves, how society views us and how we view ourselves when we stand in front of a mirror.

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GeriPal

DECEMBER 15, 2022

Heather: I do Alex, and I’m so happy to have this song request, it’s called The Eye by Brandi Carlile, which comes from a quite old 2015 album called The Firewatcher’s Daughter. Summary Transcript Summary. But wait, there’s a shiny new anti-amyloid drug, lecanemab! (No No it’s not just the French version of Aducanumab). .

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FDA Law Blog

FEBRUARY 7, 2024

Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines.

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GeriPal

MARCH 2, 2023

By 2015 that number increased to 4% of US adults. In 2002, 1% of adults were taking gabapentinoids (gabapentin and or pregabalin). 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. Tasce: I do. Tasce: Yes. Eric: Yeah.

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GeriPal

MAY 18, 2023

We’ve invited two members who helped update the criteria including Todd Semla and Mike Steinman. We discuss a little history of the Beers criteria, including the original Beers Criteria that was published by the late Dr. Mark Beers, and how it has evolved over the last three decades. Alex: We’re having Beers. We’ll learn about that.

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GeriPal

JANUARY 18, 2024

We start off the conversation by talking about whether patients with cancer and cancer pain are really that different, and their paper that was just published on January 11 th in JAMA Oncology showing that substance use disorder is not uncommon in individuals with cancer. AMA PRA Category 1 credit(s) ™. Jessie, welcome back to GeriPal.

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GeriPal

DECEMBER 8, 2022

Heather: I do Alex, and I’m so happy to have this song request, it’s called The Eye by Brandi Carlile, which comes from a quite old 2015 album called The Firewatcher’s Daughter. Summary Transcript Summary. Eric and I weren’t sure what to call this podcast – storytelling and medicine? Narrative medicine? Here we go.

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FDA Law Blog

DECEMBER 18, 2022

Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction. FDA began an initial VMSR pilot program in 2015. In that letter, FDA stated that it would “permit manufacturers.

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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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GeriPal

OCTOBER 26, 2023

I moved to Boston in 2015 to start my PhD and I’ve always worked clinically at MGH during the process, but I was very interested in this notion of measuring function and frailty. Eric: And probably, you didn’t have to twist Alex’s arm for a Neil Diamond song. Ann: No, he was very excited. Here we go. singing) Ann: Great job.

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GeriPal

DECEMBER 14, 2023

On this podcast we talk about her paper in JAMA Internal Medicine which studied three hospitals that varied in the intensity of care they provided to seriously ill patients. This field is not new. In his book The Hour of our Death Philip Aries described a long evolution in western civilization of cultural attitudes towards dying.

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GeriPal

JANUARY 11, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Four percent.

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GeriPal

AUGUST 25, 2022

I had looked at a research article that had recently evaluated the prevalence of private equity transactions in the hospice market and noted that there was a pretty substantial uptick in the past decade, and really over the course of say around 2015 to 2019. We’re going to be talking about each one of these papers. Is it you, Melissa?

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GeriPal

JUNE 30, 2022

Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia. Samir: Thanks, Alex and Eric. Before we go into this topic, who has a song request for Alex? It was Remember Me. Was that the title? Alex: I think it’s I Will Remember You. Alex: By … Joel: Sarah McLachlan.

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Patient-Centered Complication Patients IT 101

GeriPal

MARCH 3, 2022

Alex: And we’re delighted to welcome you to the GeriPal Podcast, Julien Cobert, who is an intensivist and aging researcher GeriPal Podcast, Julien. Julien: Thanks Alex, thanks Eric. It’s great to be here. Eric: So we’re going to be talking about aging in the ICU. Chris Cornell is one of my favorite musicians. Alex: (Singing).

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FDA Law Blog

FEBRUARY 16, 2023

Many states already have standing orders that allow for the dispensing of naloxone without an individual prescription and other public health initiatives to increase naloxone access. February 2023 Advisory Committee for NNS Rx-to-OTC Switch Narcan Nasal Spray was originally approved by FDA in November 2015 (NDA 208411).

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FDA Law Blog

AUGUST 21, 2023

Interestingly, the Plaintiffs alleged that this duty existed when the mother was pregnant in 2015 even though the studies relied upon in the litigation are from 2021. Koblitz & Deborah L. Agency officials estimated that it took at least 6 years to complete the required rulemaking process.” But we digress.

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GeriPal

DECEMBER 7, 2023

was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US.

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Healthcare IT Education Hospital 130

GeriPal

JULY 25, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. You got it.

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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.” Malaz: I love it.

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Patient-Centered IT Family Families 126

GeriPal

JANUARY 5, 2023

“Typically when we think about conscience in medical ethics we think about it in terms of a negative claim of conscience, where a clinician refuses (or objects) to provide care. Lisa was writing about providing abortion care, but she just as easily could have been writing about providing medical aid in dying in states where it is illegal.

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FDA Law Blog

SEPTEMBER 14, 2021

The most far reaching drug pricing provision of Subtitle E is an amendment to the Social Security Act to establish a Fair Price Negotiation Program applicable to Medicare Parts B and D as well as group and individual health plans in the commercial market. PART 2: INFLATION REBATES UNDER MEDICARE PARTS B AND D.

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FDA Law Blog

NOVEMBER 8, 2023

The rule established a new category of OTC hearing aids for individuals with mild to moderate hearing loss, allowing them to purchase hearing aids directly from stores or online retailers without the need for a medical examination, prescription, or fitting adjustment by an audiologist.

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Physicians News Digest

APRIL 3, 2025

Survey data gathered by AHRQ provides much of what is known about hospitalizations for motor accidents, measles, methamphetamine, and thousands of other medical issues. Haskell, of Columbia, South Carolina, has done research and helped write AHRQ-published surveys and guidebooks on patient engagement for hospitals.

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