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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FDA Law Blog

JUNE 29, 2022

Breakthrough Therapy Designation (BTD) was created in 2012 as part of the FDA Safety & Innovation Act (FDASIA). Prior to issuance of this Draft Guidance, information about this previously little-used process was included in a variety of sources we describe below.

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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. Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. That did not happen.

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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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FDA Law Blog

APRIL 3, 2023

Vanda is also conducting clinical studies of a long-acting injectable form of its marketed drug Fanapt tablets, an anti-seizure drug. This objection echoed a criticism that had been expressed by industry ever since CMS’s proposed rule in 2012. NDA or BLA) drugs. All of these products are line extensions under CMS’s definition.

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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. Each of these De Novos can represent a clinical advance. This amendment allowed sponsors with low or moderate risk devices to proactively employ the De Novo process.

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FDA Law Blog

MARCH 1, 2023

In this report, it’s stated that 62% of drug shortages reported between 2012 and 2017 were due to quality issues which is attributed in part to a lack of recognition or reward for manufacturers with mature quality management systems that focus on continuous improvement and early detection of supply chain issues. By Holly N.

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PEMBlog

MAY 11, 2023

Pediatr Emerg Care This randomized, double-blinded, placebo-controlled trial in infants 0-3 months old getting an LP, younger than 3 months, presenting to the ED meeting clinical criteria for LP. 2012 Jul;28(7):687-90. This helps to open up the spaces between the vertebrae and makes it easier for the needle to enter. doi: 10.1097/PEC.0b013e31825d210b.

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Pamela Wible MD

JUNE 20, 2025

During that time, psychologist Herbert Freudenberger volunteered at a New York City free clinic treating addiction. He overheard the term and used it to describe himself and clinic staff in a 1974 article on staff burnout detailing long-term physical and psychological job stress. They’re suffering from moral injury. Not burnout.

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FDA Law Blog

JUNE 9, 2025

These events marked a turning point in expanding representation in clinical studies and opening the door to more personalized medical care. These events marked a turning point in expanding representation in clinical studies and opening the door to more personalized medical care.

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Annals of Family Medicine

NOVEMBER 20, 2024

Conclusions This study shows wide variation among HPV vaccine uptake among children and adolescents in a multi-state network of community-based clinics, with higher uptake in Latino patients, especially foreign-born Latinos. It remains uncertain how ethnicity and country of birth relate to HPV vaccination among younger Latinos.

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Common Sense Family Doctor

DECEMBER 4, 2024

A recent editorial in the Journal of the American Heart Association discussed a “paradigm shift” in management of severe aortic stenosis: 69% of Medicare fee-for-service beneficiaries who underwent aortic valve replacement from 2012-2019 had TAVI, with the percentage undergoing SAVR falling from 75% in 2012 to just 10% in 2019.

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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). This has been a decision we’ve been closely following. What do we mean?

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Physician's Weekly

JUNE 19, 2025

Data came from the three influenza seasons from 2012 to 2015. While RSV types A and B showed no significant differences in clinical outcomes, chronic obstructive pulmonary disease and chronic kidney disease emerged as factors associated with disease severity, alongside frailty,” the researchers wrote.

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FDA Law Blog

MARCH 13, 2023

Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision about whether to participate in a clinical trial, and what kind of treatment effects would be most meaningful to them?

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PEMBlog

JUNE 2, 2025

Clinical Case You are a senior resident working in the busy emergency department on an overnight shift. Hypertensive emergency is a clinical diagnosis characterized by a sudden and severe elevation in blood pressure accompanied by signs of acute end-organ dysfunction. Look for the underlying cause renal disease leads the list in kids.

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Permanente Medicine

APRIL 29, 2025

From 2012 to 2016, death rates from colorectal cancer among Black people were nearly 40% higher than in whites and double that seen in Asians and Pacific Islanders, according to the American Cancer Society. Deaths per 100,000 for Hispanic, white, and Asian patients decreased to 20 during the same time period.

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GeriPal

MARCH 2, 2023

By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications. The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia.

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The Clinical Problem Solvers

NOVEMBER 16, 2020

37:50​ Race vs. ancestry vs genetics–implications for research and clinical practice 52:02 ​What can we start doing tomorrow? Given that there is no standard definition of race, its imprecision does not meet the standards of clinical medicine. How is race a social construct? Why was it constructed in the first place?

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GeriPal

FEBRUARY 2, 2024

First, in our editorial, we expressed concern about the length of stay metric not being patient centric, though important for health systems focused on cost savings. It was refreshing to hear Scott and Kate express similar sentiments. Much more to come. And I get to play Phish, who Scott has seen about 100 times in concert. I saw them only twice.

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PEMBlog

DECEMBER 14, 2023

2012 Oct;147(4):619-26. But it might underestimate it because lots of mild cases don’t actually present clinically, and they’re not diagnosed endoscopically. Laryngomalacia, is the most common cause of infant stridor. Early diagnosis is crucial as it can impact a child’s growth and development. 2005 Nov;128(5):3391-7.

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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. Cervical Spine Injuries are fortunately rare in children. Here is the aforementioned PECARN paper: Leonard, J.

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FDA Law Blog

APRIL 8, 2024

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

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GeriPal

MARCH 7, 2024

There’s an organization that I took my training from, which began, I want to say, in 2012. But before we jump into that topic, John, do you have the song request for Alex? John: I do. It’s Jimmy Buffett’s song, Bubbles Up. It was on his last album. As you may know, Jimmy Buffett passed away in August of a rare skin cancer.

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PEMBlog

APRIL 26, 2023

Pediatrics November 2012; 130 (5): e1416–e1423. 2012-2481 Haasz, M., 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. Pomerantz, Elizabeth C. Powell, Seth J. Scholer, Gary A. 10.1542/peds.2012-2481 Beidas, R. S., & Betz, M.

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GeriPal

MARCH 20, 2025

I was part of a writing group that wrote clinical guidelines for VSET for voluntarily stopping eating and drinking. Eric 00:13 And Alex, who do you have with us today? Alex 00:14 We have a very full house today. Hope Wechkin brought this topic to us. Thank you, Hope, for bringing a topic to us. We love it when our guests suggest things.

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GeriPal

AUGUST 1, 2024

Summary Transcript Summary What is a healthy diet and how much does it really matter that we try to eat one as we age? That’s the topic of this week’s podcast with three amazing guests: Anna Pleet, Elizabeth Eckstrom, and Emily Johnston. Emily Johnston is a registered dietitian, nutrition researcher, and Assistant professor at NYU.

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Common Sense Family Doctor

MARCH 23, 2025

We make evidence that other groups use to make guidelines"), the passage of the Affordable Care Act made AHRQ a target again in 2012, when a House appropriations subcommittee voted to zero out its budget again. Now the Department of Government Efficiency is trying again, threatening 90% staff reductions that would decimate the agency.

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GeriPal

APRIL 17, 2025

What a Wonderful World could be sung in irony at this moment. I hope we all take it literally, with the hope this podcast ends with. Alex Smith ** This podcast is not CME eligible. To learn more about CME for other GeriPal episodes, click here. Transcript Eric 00:00 Welcome to the GeriPal Podcast. It is a terrific book. Alex 02:07 Yeah, I love it.

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