FDA Law

AUGUST 18, 2024

In 2012, the FDCA was modified to allow the submission of a De Novo request without the need for a prior 510(k), and set a target review time by FDA of 120 days. calendar years is both inexplicable and deprives patients and clinicians of options. FDA’s failure to post decision summaries for 70% of De Novos granted in the last 2.5

Specialization 69

Specialization Hospital Physicals Provider 69

FDA Law

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. That PTE application was submitted to the PTO on July 26, 2012. 6,953,787 [] for [PTE] request under 35 U.S.C. §

Clinic 59

Clinic IT Provider Patient-Centered 59

Pamela Wible MD

JUNE 20, 2025

(Published 3/18/19, updated 6/20/25) What Is Physician “Burnout”—and Why It Matters Physician “burnout” is a state of emotional, physical, and mental exhaustion caused by prolonged stress in the medical workplace. So why are physicians experiencing physical and mental collapse from overwork? Not burnout.

Medical Student 246

Medical Student Diagnosis Physicals Medical 246

FDA Law

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

Clinic 64

Clinic Relationship Provider IT 64

PEMBlog

JUNE 2, 2025

Upon entering the room, you find the patients nurse at the bedside already in mid-conversation with the patients parent. In pediatric patients, this condition should be considered when blood pressure exceeds the 95th percentile for age, height, and sex by more than 30 mm Hg, or reaches levels above 180/120 mm Hg in older adolescents.

Hypertension 75

Hypertension Management Physicals Lab Testing 75

PEMBlog

MAY 24, 2023

Patient that are agitated should always be treated with dignity and respect. This entails utilizing the least invasive non-pharmacologic means of assisting them, before moving to physical or chemical restraints. Deaths due to physical restraint. 2012 Jan;109(3):27-32. Physical and chemical restraints. PMC3272587.

Management 54

Management Patient-Centered Physicals Transportation 54

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. There are a lot of reasons that may explain the massive increase in use of these drugs.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

PEMBlog

DECEMBER 14, 2023

2012 Oct;147(4):619-26. Tracheomalacia and bronchomalacia in children: incidence and patient characteristics. The physical exam of a Child with possible laryngeal malaysia focuses on the airway and breathing naturally. Maybe up to three out of five patients will need a trach due to ongoing airway obstruction.

Diagnosis 52

Diagnosis IT Diagnose Patients 52

PEMBlog

JUNE 5, 2024

Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. 2012 Jan 13;61(RR-1):1-20. The most common injuries seen in these younger patients are growth plate fractures and ligamentous injuries. MMWR Recomm Rep. PMID: 22237112. than it is spinal shock.

Patient-Centered 52

Patient-Centered Patients IT Hospital 52

GeriPal

APRIL 17, 2025

Summary Transcript CME Summary I read Farah Stockmans article in the NYT on why attacks on DEI will cost us all , and thought, Yes, and everyone includes harm to our healthcare workforce, our patients, and their families. I’m asking you, have you ever walked in and talked to a black, older black patient and used their first name?

IT 71

IT Community Government Management 71