FDA Law Blog

JANUARY 12, 2025

As such, we will publish a separate blog post focused on confirmatory trials and how FDA is interpreting this key provision of its accelerated approval authority. First, patients may be exposed to safety risks from a drug that subsequently fails to demonstrate clinical benefit.

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FDA Law Blog

NOVEMBER 1, 2023

Indeed, recent jurisdictional developments suggest that a wide of array of stakeholders could have standing to challenge the Agency’s attempt to restrict access to commonly used LDTs, including individual laboratories, hospitals, physicians and healthcare providers who routinely use these tests, and patients who depend on them.

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PEMBlog

OCTOBER 2, 2024

I’ll make the important distinction between gastritis – which is diagnosed only via endoscopy – and dyspepsia, the term best used to describe the symptoms many patients experience. Gastroesophageal reflux disease is when the patients have severe symptoms that persist and cause long term issues.

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FDA Law Blog

JUNE 22, 2022

It was alleged that other employees administered the medication to patients even after observing signs of tampering, although no patients were reported harmed. It is worth noting that the nurse was separately sentenced to 4.5 Press Release, DOJ, Nurse Sentenced to 54 Months for Drug Tampering (June 1, 2022).

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FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC). By Holly N.

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FDA Law Blog

FEBRUARY 29, 2024

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. According to documents in the PTO’s Patent Center, Lilly has not yet filed a response.

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Clinic IT Provider Patient-Centered 59

Rao Doctor

APRIL 3, 2025

Rectal method is more appropriate for infants, children and unconscious or comatose patients who are not able to hold the thermometer in their mouth. The choice of method depends on the patient’s age, condition, and preference, with rectal measurements often being the most precise for infants and young children.

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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. A few data based publication links from Person-Centered Narrative Intervention Program of Research: .

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GeriPal

FEBRUARY 29, 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.

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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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PEMBlog

JULY 10, 2024

Labudde, Jane Lee; A Review of Syphilis Infection in Pediatric Patients. link] Centers for Disease Control and Prevention. ” Centers for Disease Control and Prevention, 2021. Centers for Disease Control and Prevention. ” Centers for Disease Control and Prevention, 2021. . Pediatr Rev.

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FDA Law Blog

JANUARY 18, 2024

Controlled substances that have an accepted medical use are classified in schedules II-V based on their relative potential for abuse and physical and psychological dependence. or a currently accepted medical use with severe restrictions; and The drug’s relative safety or ability to produce physical dependence compared to other drugs.

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PEMBlog

JUNE 5, 2024

Sasser SM, Hunt RC, Faul M, Sugerman D, Pearson WS, Dulski T, Wald MM, Jurkovich GJ, Newgard CD, Lerner EB; Centers for Disease Control and Prevention (CDC). Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. Lancet Child & Adolescent Health. MMWR Recomm Rep.

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GeriPal

FEBRUARY 9, 2023

For example, we spend the first half talking about a RCT simulation study of clinician verbal and non-verbal communication with a seriously ill patient with cancer. In one room the physician under study interacts with a white patient-actor, and in another room interacts with a Black patient-actor.

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GeriPal

SEPTEMBER 22, 2022

Have you ever had that moment when talking to a patient, when you realized that the phrase you just uttered, which you’ve uttered a hundred times before, came out rote and scripted? And in response, the family or patient looked at you like you were from another planet? Summary Transcript Summary. Yeah, I’ve been there too.

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Illness IT Patient-Centered Patients 102

GeriPal

MARCH 3, 2022

This idea that for critically ill patients in the ICU, geriatric conditions like disability, frailty, multimorbidity, and dementia should be viewed through a wider lens of what patients are like before and after the ICU event was transformative for our two guests today. GeriPal podcast with Linda Fried on frailty.

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FDA Law Blog

JULY 11, 2021

We note that the Centers for Disease Control and Prevention reported in December that over 81,000 drug overdose deaths occurred in the year ending May 2020, the highest number ever recorded during a twelve-month period. They cannot transport patients. 33,861 (June 28, 2021). Overdose Deaths Accelerating During Covid-19 (Dec.

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GeriPal

DECEMBER 19, 2024

A NY Times article titled Should Patients Be Allowed to Die From Anorexia ? It’s one of the core things that we think about palliative care is you got the physical, psychological, social and spiritual symptoms. That’s how do we treat the mental health needs of patients with serious medical illness?

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GeriPal

JANUARY 11, 2024

In further contrast to the United States, MAID in Canada is almost entirely administered by a clinician, whereas in the United States patients must self administer. Alex: And we’re delighted to welcome Sonu Gaind, who is a Chief of psychiatry and professor at the Sunnybrook Health Sciences Center at the University of Toronto.

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GeriPal

SEPTEMBER 19, 2024

Give too much, it may cause harm (even if the higher dose had no significant side effects, it would require patients to take a lot of unnecessary additional pills as well as increase the cost.) So, what is the effective dose of palliative care? Give too little – it may not work. This is Eric Widera. Jennifer 04:25 I can take that on.

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FDA Law Blog

MAY 21, 2024

and its abuse may lead to only moderate or low physical dependence or high psychological dependence. Marijuana’s Psychic or Physiological Dependence Liability HHS concluded that “experimental data and clinical reports demonstrate that chronic, but not acute, use of marijuana can produce both psychic and physical dependence in humans.”

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Pamela Wible MD

JUNE 19, 2025

In order to heal her patients she first had to heal her ailing profession. And this is a medical system that needs to be disrupted because our medical system (as you know) is endangering the lives of patients right now—and physicians. I give you Dr. Pamela Wible. Born into a family of physicians who warned her not to pursue medicine.

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FDA Law Blog

NOVEMBER 18, 2024

Incentives to motivate better nutritional choices and increase physical fitness would be welcome. He states, correctly, that PDUFA user fees make up about 75% of the budget for the Center for Drug Evaluation and Research (CDER). In the meantime, this belief was followed for centuries by doctors, to the detriment of countless patients.

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