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.

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

The Clinical Problem Solvers

MARCH 4, 2024

During this episode, we hear from Zahra Khan, an educator and editor who has written extensively on abolition in medicine, and Dr. Sayantani DasGupta, a physician-educator, prolific children’s book author and faculty at the Center for the Study of Ethnicity and Race and the Institute for Comparative Literature and Society at Columbia University.

Community 52

Community Education Patient-Centered Relationship 52

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution.

Illness 109

Illness IT Patient-Centered Patients 109

FDA Law Blog

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By Larry K. HHS forwards FDA’s analysis and recommendation to DEA.

Medical 69

Medical Physicals IT Healthcare Professional 69

GeriPal

FEBRUARY 8, 2024

2023 Dec 20:S1524-9042(23)00202-3. I think even the word patient, patient, I think, comes from the word suffer, the one who suffers. More of the point is we get in big trouble with ourselves and with our patients and each other if we go down that comparison track too far, I think that we can cause some real trouble there.

IT 137

IT Families Family Physicals 137

PEMBlog

JANUARY 16, 2025

Well dive into the clinical presentations, including acute and chronic symptoms, the dangers of sudden sniffing death, and the specific risks associated with nitrites, hydrocarbons, and nitrous oxide. Formulate effective strategies for identifying, managing, and preventing inhalant misuse in pediatric patients. Ganetsky M (ed).

Complication 52

Complication Patient-Centered Management Patients 52

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. Amber: Thank you guys.

Patient-Centered 112

Patient-Centered Patients IT Healthcare 112

GeriPal

APRIL 6, 2023

Today we have a star-studded lineup, including Lexy Torke of Indiana University, who discusses her RCT of a chaplaincy intervention for surrogates of patients in the ICU , published in JPSM and plenary presentation at AAHPM/HPNA. These studies are important. Randomized controlled trials of chaplaincy interventions.

IT 99

IT Patient-Centered Families Family 99

FDA Law Blog

MAY 21, 2024

and its abuse may lead to only moderate or low physical dependence or high psychological dependence. 29, 2023) (“Basis”); NPRM at 44,603. In 2023, HHS conducted a different approach, a two-part test, to determine whether marijuana has a CAMU. 21 U.S.C. § Basis at 18; NPRM at 44,605. Basis at 24. NPRM at 44,607.

Physicals 69

Physicals Medical Clinic Emergency Room 69

GeriPal

AUGUST 15, 2024

Ongoing reports from patients about anti-Asian hate experiences Should clinicians screen for Anti-Asian hate? This question, while providing an opportunity to talk about direct and indirect experiences, can be asked of all patients, and opens the door to conversations about anti-semitism, islamophobia, or anti-Black racism.

Mental Health 118

Mental Health Community Screening IT 118

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.”

Patient-Centered 126

Patient-Centered IT Families Family 126

GeriPal

SEPTEMBER 14, 2023

We talk with Bruce Leff and Tacara Soones about the hospital-at-home movement, which has been shown to reduce costs, improve outcomes and improve the patient experience. JAGS Hospital-at-Home Interventions vs In-Hospital Stay for Patients With Chronic Disease Who Present to the Emergency Department: A Systematic Review and Meta-analysis.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115

GeriPal

JULY 20, 2023

Clinicians could care for patients across state lines, could prescribe opioids without in person visits, could bill at higher rates for telemedicine than previous to the pandemic. Many patients benefited, not only those isolating due to covid, but also patients in rural areas, patients who are homebound, and many others.

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73

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.

Appointment 116

Appointment Vaccination Patient-Centered IT 116