FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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PEMBlog

SEPTEMBER 13, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not.

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FDA Law Blog

NOVEMBER 20, 2024

KP Medical Device Consulting LLC By Adrienne R. We have concerns that FDA’s expectations related to chemical identification levels may be unattainable even despite proper information gathering and additional orthogonal data and represent an unwillingness to accept some residual level of uncertainty in their decision-making process.

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Provider Medical Manufacturing Consulting 59

GeriPal

JANUARY 18, 2024

After discussing screening options for substance use disorder, we go on to talk about both the treatments for it and the issues that arise. And you wrote, actually, a beautiful GeriPal blog about it a while ago. I mean, the simple answer is, yes, we should be screening people for substance use disorder. What is it called?

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Illness Patient-Centered Screening Clinic 136

PEMBlog

MARCH 27, 2024

Now, newborn screening, or NBS, includes testing newly born infants for certain IEMs. So those would be a plasma sample for plasma amino acids, organic acids, acyl carnitine, other compounds, which your friendly geneticist, when you consult them will be incredibly happy you got. your genetics consult hasn’t responded yet.

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FDA Law Blog

JULY 7, 2024

The guidance also reminds readers of the somewhat illusory protection offered by enforcement discretion, noting that “FDA retains discretion to pursue enforcement action for violations of the FD&C Act at any time and intends to do so when appropriate.”

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Manufacturing Provider Physicals Electronics 64

FDA Law Blog

JULY 9, 2024

We’ve blogged about some of FDA’s efforts to increase diversity in clinical trials previously, and the Draft Guidance itself describes a variety of these efforts. FDA encourages sponsors to consult patients and healthcare providers to assist in developing such strategies.

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GeriPal

APRIL 18, 2024

I remember walking through San Francisco Airport with Bob, we just happened to be there at similar times, and saying, “Eric and I are thinking about starting a blog.” Alex: Yeah, we talk a lot about de-skilling in geriatrics and palliative care, because so much of what we do is a consultant role.

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