FDA Law Blog

MAY 25, 2022

Javitt — On April 19, FDA issued a safety communication regarding genetic non-invasive prenatal screening, commonly referred to as non-invasive prenatal tests or NIPT ( here ). NIPT are intended to screen for genetic abnormalities in a fetus.

Provider 40

Provider Screening Medical Patients 40

FDA Law Blog

JULY 10, 2023

By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Day 90 FDA sends final MDUFA Decision on 510(k).

Provider 75

Provider IT Engineering Medical 75

FDA Law Blog

OCTOBER 5, 2022

Instead, it will go through a virus scanning and technical screening process to verify that eSTAR responses accurately describe the device and there is at least one applicable attachment per relevant attachment-type question. The submitter would select “Additional Information” in eSTAR and see a pop up that provides information on next steps.

Electronics 45

Electronics Medical Screening IT 45

GeriPal

FEBRUARY 6, 2025

How should we screen for cognitive impairment? Who do you think we should be screening and how should we be screening them for these symptoms? Well, so I guess it depends on what you say screening. That screening influences kind of further treatment, actually, probably more importantly, patient outcomes.

Primary Care 96

Primary Care Diagnosis Screening IT 96

The Clinical Problem Solvers

FEBRUARY 8, 2023

Screening for substance use and offering connections to treatment and community-based services are important strategies that clinicians can implement in their own practice today. They can use their training and privilege to advocate for meaningful policy reform. The opioid epidemic is more than a white problem.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. And yet, after assisting the older adult to their feet, the EMS providers would leave. I think, as providers, we don’t get to see that.

Community 115

Community Transportation IT PCP 115

GeriPal

JULY 21, 2022

Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. So that’s a piece that I think is important for providers anywhere along that process to be asking about driving. We and many others have tried to come up with a short, validated screening tool.

Families 102

Families IT Family Diagnosis 102

GeriPal

SEPTEMBER 7, 2023

William: So ASCO decided to make a high priority this year to redo the guidelines, which were originally released in 2018. Because a lot of my colleagues, who are like transplant coordinators for example, are asking, “Can you help us better screened for which older adults would be fit enough to go for transplant?

Patient-Centered 129

Patient-Centered IT Patients Clinic 129

GeriPal

APRIL 3, 2025

We covered: The first parody song I wrote, for AGS 2018 in Orlando , about this article by Nancy Schoenborn on how to discuss stopping cancer screening. Alex joined in 2018. This was 2018 in AGS Orlando, and they did a song about when to stop screening for cancer for colon cancer. Alex 05:15 Oh, really?

IT 64

IT Hospital Screening Patients 64

FDA Law Blog

APRIL 7, 2025

The omitted phrase therefore provided material facts that may be relevant to prescribing veterinarians and dog owners. While there is some animal-related risk information included in superimposed text at the bottom of the video screen for a portion of the video.

Vaccination 64

Vaccination IT Manufacturing Screening 64

GeriPal

JULY 13, 2023

Summary Transcript Summary Today’s podcast is a follow up to our 2018 podcast with Randy Curtis about the Jumpstart intervention. I wonder if we can just start off just going back a little bit because we had Randy on back in 2018 talking about Jumpstart, priming patients to do goals of care conversations. Am I summarizing that right?

Patient-Centered 84

Patient-Centered IT Hospital Patients 84

GeriPal

APRIL 21, 2022

To the deeper emotions – of loss and grief, of wonder and transcendence – that are at the heart of the complex care we provide. And along the way, we really felt like we got to the heart of things. AlexSmithMD . Links to Redwing’s poetry workshops: Food for Thought Poetry for Resiliency. Wounded Healer poetry sessions .

Patient-Centered 93

Patient-Centered IT Community Illness 93

GeriPal

FEBRUARY 24, 2022

And so the definition of advance care planning really switched in, I think, 2017, 2018, there was kind of a United States definition and then an international consensus definition. So I’m just going to share on my screen. And I also think, we still operate under pay for… We get paid for the services we provide, right?

Illness 98

Illness Patient-Centered IT Families 98

Physicians News Digest

APRIL 2, 2025

We were so nervous about not being on a company-provided plan,” Winard said. The Medical Procedure Periodic colon cancer screening is recommended for people at average risk starting at age 45 and continuing until age 75, according to the U.S. There are several ways to screen, including noninvasive stool tests.

Insurance 52

Insurance Screening Hospital Patient-Centered 52