FDA Law Blog

AUGUST 18, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use.

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FDA Law Blog

JUNE 23, 2021

In 2012 we at the Agency, under Dr. Janet Woodcock’s leadership, identified the need for more systematic patient engagement — a way to improve representativeness and be more proactive rather than reactive to interacting with patient communities. However, the scope of patient input goes beyond setting the clinical context.

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PEMBlog

MAY 11, 2023

And what about the J-Tip, a device that uses pressurized gas to send medication into the subcutaneous portion of the skin – deeper than topical anesthetics? Neither HR nor NCFS differed, and perception of pain by provider, and need for additional lidocaine were similar. 2012 Jul;28(7):687-90. 95% confidence interval = 1.01-3.93;

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Patient-Centered IT Provider Patients 52

PEMBlog

JUNE 2, 2025

Clinical Case You are a senior resident working in the busy emergency department on an overnight shift. Before your blood pressure rises as well, know that this PEMBlog article is here to provide an overview of the recognition and management of hypertensive emergencies. All kids with hypertensive emergency need ICU-level care.

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FDA Law Blog

JUNE 7, 2021

However, the FDA guidance goes on to say in some cases, additional context is needed by specifically inserting a sentence in the indications statement that: no clinical benefit has been established. be “reasonably likely to predict” ultimate clinical benefit). be “reasonably likely to predict” ultimate clinical benefit).

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GeriPal

MARCH 2, 2023

Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US. Eric: Are these generic? Nisha: Both of them are generic, yeah.

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GeriPal

MARCH 7, 2024

We are delighted to welcome Jane Euler, who is lead doula and co-founder of Present for You, which is a benefit LLC company that provides doula support at the end-of-life. We are doulas for those with serious illness and those at end-of-life, just a longitudinal relationship, nonmedical support to provide presence. Jane: Right.

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FDA Law Blog

APRIL 8, 2024

MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. Unfortunately, the White Paper does not provide further analysis on the generic sterile injectables and instead refers back to FDA’s analysis from 2013-2017. In Section I.A,

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Supply Chain Manufacturing Government Hospital 59

PEMBlog

APRIL 26, 2023

Pediatrics November 2012; 130 (5): e1416–e1423. 2012-2481 Haasz, M., I’m Dr. Carney and I am a pediatric resident at Cincinnati Children’s Hospital Medical Center. Today, we are going to discuss firearm safety and ways to screen for it in both the ED and clinic settings. Melzer-Lange, Joseph O’Neil, Wendy J. Beidas, R.

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PEMBlog

JUNE 5, 2024

It was inspired by a hot-off-the-presses publication from the Pediatric Emergency Care Applied Research Network (PECARN) focused on clinical decision rules for cervical spine imaging in children. 2012 Jan 13;61(RR-1):1-20. If they have no pain in the midline with any of these movements, then the cervical spine is clinically cleared.

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Patient-Centered Patients IT Hospital 52

GeriPal

MARCH 20, 2025

Summary Transcript CME Summary Eric and Alex have featured discussions about complex bioethical concepts around caring for people at the end of life, including voluntarily stopping eating and drinking ( VSED ), and multiple episodes about the ethical issues surrounding medical aid in dying ( MAID ). Alex 00:14 We have a very full house today.

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IT Patient-Centered Patients Medical 87

GeriPal

FEBRUARY 2, 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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Consulting Hospital Patient-Centered IT 120

GeriPal

AUGUST 1, 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

APRIL 17, 2025

Farah provides clear examples from the Biden administration, in which having the most diverse cabinet in history was critical to building bridges, empathy, and inspiring others to feel included. Alex 20:58 Farah, appreciate the medicine metaphor for our clinical audience. That looks at what the Baha’is have been doing since 2012.

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