FDA Law Blog

AUGUST 10, 2023

Section 704(a)(4) was added to the FDCA by the Food and Drug Administration Safety and Innovation Action (FDASIA) in July 2012. Despite FDA having the authority to conduct paper inspections since the statutory provision was added to the FDCA by FDASIA in 2012, FDA did not issue a warning letter citing Section 704(a)(4) until January 2021.

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Manufacturing Electronics IT Physicals 52

FDA Law Blog

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. This amendment allowed sponsors with low or moderate risk devices to proactively employ the De Novo process.

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Specialization Hospital Physicals Provider 69

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

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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.

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Medical Student Diagnosis Physicals Medical 246

FDA Law Blog

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).

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Clinic Relationship Provider IT 64

PEMBlog

JUNE 2, 2025

Recognizing Hypertensive Emergencies The end-organ dysfunction component of this diagnosis presents as particular symptoms, physical exam findings, or laboratory and imaging results. 2012 Sep 5;4:85-92. Quick References 2024; 10.1542/aap.ppcqr.396258. Patel NH, Romero SK, Kaelber DC. Open Access Emerg Med. doi: 10.2147/OAEM.S32809.

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Hypertension Management Physicals Lab Testing 75

PEMBlog

MAY 24, 2023

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. 2012 Feb;13(1):35-40. Dtsch Arztebl Int. PMC3272587. Coburn VA, Mycyk MB. 2009.07.003.

Management 55

Management Patient-Centered Physicals Finance 55

PEMBlog

DECEMBER 14, 2023

2012 Oct;147(4):619-26. The physical exam of a Child with possible laryngeal malaysia focuses on the airway and breathing naturally. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: [link] Hartl TT, Chadha NK. A systematic review of laryngomalacia and acid reflux. Otolaryngol Head Neck Surg.

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Diagnosis IT Diagnose Patients 52

GeriPal

MARCH 2, 2023

There was this big thing called the CMS National Partnership to Improve Dementia Care, started in 2012. And so surgeons have been really reaching for other medications and what’s called a multimodal pain regimen after surgery to decrease use or even completely eliminate use of opioids in certain procedures.

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Patient-Centered IT Healthcare Medical 96

PEMBlog

JUNE 5, 2024

2012 Jan 13;61(RR-1):1-20. When it comes to physical examination of a child with a suspected cervical spine injury, remember, immobilize the c spine, either by hand, so another team member holding inline c spine, or by placing a collar, like an Aspen or Miami. MMWR Recomm Rep. PMID: 22237112.

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Patient-Centered Patients IT Hospital 52

GeriPal

APRIL 17, 2025

You look at the physical body and you ask yourself, can you afford to lose diversity? That looks at what the Baha’is have been doing since 2012. And they ended up not making the change. It was a foolish change. It would have wasted money and it wouldn’t have improved patient care. You have to have diversity.

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IT Community Government Management 70