FDA Law

AUGUST 11, 2024

FDA’s stated concern from a public health perspective is that the omission of risk information “fails to provide material information about the consequences that may result from the use of Auvi-Q and creates a misleading impression about the drug’s safety.” August 2024 Untitled Letter to Mirati Therapeutics Inc.

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Clinic Provider IT Complication 59

FDA Law

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. It is focused on the nutrients in the food product rather than on it overall nutritional “quality.”.

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Provider Individual IT Manufacturing 52

FDA Law

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). l56(d)(1).

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Patients IT Provider Individual 59

FDA Law

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. However, in the coming days we hope to do so and may provide our thoughts in subsequent posts. 13, 2014).

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Patients Patient-Centered Clinic Community 52

FDA Law

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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IT Clinic Provider Medical 52

FDA Law

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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Government IT Provider Healthcare 40

FDA Law

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. And in this case the presentation would be compliant whether each component was shown individually, or, when combining all three sequentially.

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IT Education Utilities Patient-Centered 40

Physician's Weekly

JUNE 22, 2025

These included how well physicians demonstrated respect, listened to individuals, explained information, and spent enough time with them. Similarly, listening was rated lower (β = −0.286, 95% CI = −0.391 to −0.181, P = 0.001), as were explanations provided by clinicians (β = −0.133, 95% CI = −0.267 to −0.000, P = 0.050).

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Individual Insurance Education Medical 59

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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Individual Community IT Chronic Condition 82

FDA Law

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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Government Electronics Education Individual 116

FDA Law

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.

Medical 59

Medical Manufacturing Individual Provider 59

GeriPal

MARCH 2, 2023

By 2015 that number increased to 4% of US adults. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? I also heard that if you look at all individuals in the US, about 4% of individuals are taking one of the gabapentinoids, 10% over 65.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

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: Exactly. Katie: Yeah.

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Illness Patient-Centered Screening Clinic 137

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. And then the second one in 2015. Eric: Do you think that’s common amongst providers?

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IT Community Patient-Centered Medical 100

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. And which of those experiences would you like to share with us that we could then write into a story that we’ll share with providers?

Patient-Centered 116

Patient-Centered Illness Healthcare IT 116

GeriPal

MAY 18, 2023

So the intention of the AGS Beers Criteria is to provide information primarily to clinicians, although to other audience as well, but medications that we consider to be potentially inappropriate in older adults. But it does kind of provide that caution, it kind of slows things down to make sure you’re really paying attention.

Medical 97

Medical IT Patients Clinic 97

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. And which of those experiences would you like to share with us that we could then write into a story that we’ll share with providers?

IT 106

IT Patient-Centered Healthcare Illness 106

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. We provide critical education. We provide critical conversations with colleagues and families to coordinate transition planning.”

Patient-Centered 133

Patient-Centered Hospital Patients IT 133

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. Eric: Yeah.

Illness 144

Illness IT Medical Provider 144

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. Basically, there’s a lot of variation amongst hospice providers.

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Family Families IT Patients 107

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. And so one of the things that I felt as a resident was moral distress around some of the treatments that we provide near the end-of-life.

Hospital 126

Hospital IT Patient-Centered Patients 126

GeriPal

JUNE 30, 2022

Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia. Eric: And what do we know about the outcomes of individuals getting these procedures, especially those with cognitive issues and dementia. Welcome to the GeriPal podcast, Samir. Samir: Thanks, Alex and Eric.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

FDA Law

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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Supply Chain Healthcare Professional Community IT 64

FDA Law

AUGUST 21, 2023

Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.) 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.

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Manufacturing Consulting Healthcare Professional Vaccination 40

GeriPal

MARCH 3, 2022

Julien, let’s start off with, congratulations by the way and Lauren too, the CHEST paper that just got published on Trends in Geriatric Conditions Among Older Adults in the ICU between 1998 and 2015. We try to make that point because it speaks to especially ICU providers, we know how bad that is. So, that part was not surprising.

Patient-Centered 96

Patient-Centered Patients IT Hospital 96

GeriPal

DECEMBER 7, 2023

was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. And we have gone from 250 members at the end of 2015 to about 26,000 right now across the United States and a number of chapters that have grown. Voting and emailing congress to advocate for systemic change (e.g.

Healthcare 130

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.

Family 108

Family Families Patient-Centered Patients 108

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.” 2015, 2016.

Patient-Centered 126

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.

Provider 19

Provider Medical Hospital Patient-Centered 19

FDA Law

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.

Manufacturing 52

Manufacturing Insurance Government Patients 52

FDA Law

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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Utilities IT Engineering Appointment 64

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. The dissolution of AHRQ is dislodging scores of experienced patient-safety experts, a brain drain that will be impossible to rectify, she said. Despite spending $1.9

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Patient-Centered Hospital Diagnose Medical 52