FDA Law Blog

OCTOBER 5, 2022

Now, according to the Center’s announcement, anyone may request access to the CCP and begin filing premarket submissions electronically. By Allyson B. Mullen — It is with great excitement that we share CDRH’s announcement that now anyone may submit premarket submissions directly to the Center through the Customer Collaboration Portal (CCP).

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Physician's Practice

JUNE 23, 2025

Recent Videos Related Content 7 signs that your practice needs a new EHR Austin Littrell June 20th 2025 Article From sluggish systems to frustrated staff, these red flags could mean it's time to upgrade your practice's electronic health record system. In short, buying technology is no longer a line item, it’s a strategic risk.

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Permanente Medicine

MAY 20, 2025

These priorities include supporting the physician workforce, utilizing data and predictive interventions to improve patient outcomes, and boosting quality and affordability for patients. Nguyen, also the chief medical officer for care navigation with the Federation, described the innovation priorities at Kaiser Permanente.

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Aspiring Minority Doctor

APRIL 18, 2021

After extending your graduation date, the year can be utilized as a research year that can help you enhance your application and build further connections. In the event you are unsuccessful at extending your graduation date or securing an internship position, options for practicing medicine tend to become severely limited.

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The Motivated MD

DECEMBER 18, 2024

Though I adhere to commonly agreed upon personal finance advice such as living ‘like a resident’ and well below your means, if you are overly frugal, you will deprive yourself of the enjoyment that is deserved when your income grows. ’ Having a high income and being wealthy are not synonymous. So, what is lifestyle creep exactly?

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FDA Law Blog

MAY 13, 2024

RWD can be collected from a wide range of sources, such as electronic health records, registries, administrative claims, pharmacy data, and feedback from wearables and mobile technology. RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.”

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FDA Law Blog

MARCH 7, 2024

Both documents also note that FDA may request copies of the DMC meeting records when the study is completed, and access to the electronic data sets used for each set of interim analysis. In such cases, the draft guidance illustrates how employing a DMC may allow a sponsor to proceed with a trial where it might otherwise have been terminated.

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FDA Law Blog

JUNE 27, 2023

Not only would this streamline the collection process, but it would enhance the quality, utility, and clarity of the information that is submitted to FDA to support allegations of misconduct. FDA now seeks comments on this very program to support its continued collection of information as required under the Paperwork Reduction Act.

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FDA Law Blog

NOVEMBER 9, 2021

Lenz, Senior Medical Device Regulation Expert — FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here ) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. This pilot program, which utilized FDA’s eSubmitter electronic submission template, ended in May 2021.

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PEMBlog

AUGUST 30, 2023

Numerous studies have found that radiographs performed in these clinical conditions rarely reveal information necessitating a change in ED management despite high CXR utilization and wide variation in both children’s specialty hospitals and general EDs. But it’s just a CXR right?

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GeriPal

JULY 19, 2024

Summary Transcript Summary The US Preventive Services Task Force (USPSTF) concluded back in 2000 that there is insufficient evidence to recommend for or against routine screening for dementia in older adults. Are there, though, populations that it may be helpful in, or should that change with the advent of the new amyloid antibodies? Should it?

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FDA Law Blog

SEPTEMBER 11, 2023

The electronic Submission Template and Resource (eSTAR) program, which we blogged about here and here , also makes the highlight reel given its aim to improve consistency and efficiency in how 510(k)s are prepared. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R.

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The Motivated MD

NOVEMBER 26, 2024

There are also homeowners insurance costs, property taxes, flood insurance (depending on where you live), any upgrades to the home, utilities (sometimes included in rent expenses), upfront costs to include a downpayment, and closing fees. I know firsthand how much anxiety can come when deciding to rent or buy a home. This is no easy feat.

Finance 52

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Physician's Practice

JUNE 25, 2025

7 signs that your practice needs a new EHR Austin Littrell June 20th 2025 Article From sluggish systems to frustrated staff, these red flags could mean it's time to upgrade your practice's electronic health record system. Baum is Professor of Clinical Urology at Tulane Medical School in New Orleans, Louisiana.

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FDA Law Blog

JUNE 21, 2023

We also note this CDRH’s effort aligns with the FDA-wide effort to utilize digital health technologies that are discussed in recent draft guidance documents as follows: Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices. By Philip Won & McKenzie E.

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FDA Law Blog

MARCH 20, 2022

In recognition that hard copy communications are slower and more cumbersome, FDA recommends that firms use electronic communications, as they lay out the details of the electronic means here , to notify the public about recalls. FDA has model recall communication templates available here that firms can utilize.

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Physician's Practice

JUNE 20, 2025

For example, practices have adopted electronic medical records (EMR) systems only to find that productivity in the practice ground to a halt. Successful practices have found ways to work around the loss of productivity and ultimately made Electronic Medical Records (EMRs) work effectively in their practices. So, you need to decide.

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FDA Law Blog

DECEMBER 6, 2024

This summary covers everything from format and contents of INDs to their submission and use of the Electronic Submissions Gateway to cross-referencing other applications to FDAs review of the IND and the associated timelines. The discussion of endpoint selection, especially with respect to accelerated approval, caught our attention.

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Physician's Practice

JUNE 19, 2025

Layer onto that the growing bring-your-own-device culture: allowing employees to sync personal smartphones with the electronic health record can “raise privacy concerns” and blur the line between work and off-hours browsing, warns a HIPAA BYOD briefing. Against that backdrop, a technology and device policy is no longer a “nice to have.”

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The Motivated MD

SEPTEMBER 19, 2024

Before we discuss each individual savings account, let us first highlight exactly what it means to ‘automate’ your savings. A Simple Concept This is a simple concept for most visitors to my site, but it should nonetheless be reviewed. So yes, humans make mistakes. This is the same for personal finances. Fight this temptation.

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Annals of Family Medicine

NOVEMBER 20, 2024

Dataset OCHIN electronic health record data from 27 US states. Clinics should understand community strengths that might lead to robust vaccination utilization and possibly leverage these for improvement in other groups. It remains uncertain how ethnicity and country of birth relate to HPV vaccination among younger Latinos.

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GeriPal

OCTOBER 19, 2023

Summary Transcript Summary What level of evidence do we need for POLST to use it ourselves, to advocate for wider usage, and for establishing POLST completion as a quality metric? The answers to these questions will vary. Reasonable people will disagree. And today, on our podcast, our guests disagree. But is it a tiny, meaningless, fraction?

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GeriPal

JANUARY 20, 2023

He’s a geriatrician and Chair of Public Policy for the California Association of Long-Term Care Medicine. Welcome back to the GeriPal podcast, Mike. I hope I got that right. Mike: You got it right. Great to be back. Alex: And we have Jasmine Travers who’s joining us from Israel. Jasmine: Yes. Eric: Can I ask why?

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GeriPal

MAY 15, 2025

The nudge toward offering comfort care led to more hospice and early comfort-care orders. Is this due to chance alone, given the multiplicity of secondary outcomes examined? We’ve done a podcast already on nudging. Where was it? Alex 01:13 The nudging podcast We’ve done a couple I think. We also had a podcast with. Eric 02:08 Great.

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GeriPal

APRIL 10, 2025

I cant do the primary thing Ive been trained to do: ABC, ABC, ABCs. Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. They got training in Vital Talk and ELNEC. They got feedback. So did it matter? Fernanda 01:16 I do have a song request.

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GeriPal

MARCH 28, 2024

Kate: So it was an embedded alert in the electronic health record and they just clicked those two answers very quickly. I’m just stunned even writing that! We’ve come so far as a field. This is Eric Widera. Alex: This is Alex Smith. Eric: Alex, who do we have with us today? Were you at the GeriPal pub crawl? laughter] Eric: 2:30 AM.

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GeriPal

JUNE 9, 2022

How do we move from efficacy (works in highly controlled settings) from effectiveness (works in real world settings? What’s the role of implementation science? What is a pragmatic trial ? What outcomes should we measure? We cover a lot of ground! Working on a mystery. Going wherever it leads. “Runnin down a dream…” -@AlexSmithMD.

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PEMBlog

MARCH 27, 2024

She did her MD/PhD at Columbia University, where she investigated the diagnostic utility of exome sequencing for kidney disease. This episode will help you better prepare for and manage children with inborn errors of metabolism in the Emergency Department. You can contact her via email at egroopman@childrensnational.org. Take it away, Emily.

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GeriPal

APRIL 6, 2023

Practice-PC is an intentionally interprofessional and cutting edge year-long group continuing education course in palliative care for working professionals from all disciplines, in the Bay Area. It meets in-person, once a month, over nine sessions. First, the lyrics, that’s the main reason why I chose it. The theme is death. LaVera: Yeah.

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GeriPal

SEPTEMBER 19, 2024

So, basically, with a stepped care model, the goal is to tailor care delivery to the patient’s needs while at the same time utilizing less clinician resources. Summary Transcript CME Summary If palliative care was a drug, one question we would want to know before prescribing it is what dose we should give. Saw them play a couple times.

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GeriPal

JULY 6, 2023

Summary Transcript Summary You may have heard of Area Agencies on Aging, but do you really know what they do or how they do it? What about State Departments of Aging or state master plans for aging? Do you know how these agencies fit in with programs like Meals-on-Wheels or other nutritional support programs? Susan: It is my anthem.

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GeriPal

JULY 13, 2023

Today we discuss a new paper in JAMA that tests a stripped down version of the clinician only facing intervention in a pragmatic randomized trial for older adults with serious illness and those 80+. They found a difference of 4% in documented goals of care discussions. Is 4% meaningful? I think it’s you, Bob. Alex: I love that song.

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GeriPal

FEBRUARY 24, 2022

Since then there has been a lot of back and forth, with even a couple of podcasts from us, several JAMA viewpoints, and most recently a series of published replies from leaders in the field on why ACP is still valuable (see below for references). . Despite all of these publications, I’m still left at a loss of what to think about it all.

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GeriPal

JULY 20, 2023

Before we do, I think, Joe, you have a song request for Alex. Joe: I do. I would like to hear Space Oddity and it’s because I can’t imagine being more lonely and isolated than being in a tin can orbiting around the earth by myself and just how comforting it is even to hear that scratchy little voice from ground control. Joe: Right.

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