FDA Law Blog

DECEMBER 11, 2023

This is based on FDA’s reported 2018 review of the CLIA database. [2] This is 50% greater than the 2018 numbers relied upon by FDA in its estimates. [3] Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations.

IT 69

IT Medical Patient-Centered Provider 69

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.

Electronics 40

Electronics Physicals Provider Utilities 40

FDA Law Blog

SEPTEMBER 20, 2021

Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works. STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

The Clinical Problem Solvers

FEBRUARY 8, 2023

Jordan begins our episode by framing the racialization and criminalization of substance use in the larger history of the United States, emphasizing that American society has seen substance use as “criminal behavior” or a moral failing, rather than as a medical condition, which began towards the early 2000s.

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 114

Community Transportation IT PCP 114

FDA Law Blog

JANUARY 4, 2023

Prescription drug and medical device Pre-Approval Information Exchange (PIE) now has specific legal protection allowing for sponsors to proactively communicate to payors certain information about products in development to help expedite patient access upon product approval. By Dara Katcher Levy — A win for patient access!

Patients 64

Patients Provider IT Utilities 64

FDA Law Blog

JUNE 7, 2021

This sentence was included in the 2016 approval of Exondys 51 for Duchenne muscular dystrophy and the 2018 approval of Andexxa for reversal of anticoagulation therapy. be “reasonably likely to predict” ultimate clinical benefit). Yesterday’s approval of Aduhelm helped answer that.

Clinic 98

Clinic IT Private Practice Utilities 98

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 83

Patient-Centered IT Hospital Patients 83

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. And then you can make a medical recommendation that matches with what they’ve told you. Does watching a video impact utilization to that degree?

Illness 98

Illness Patient-Centered IT Patients 98

PEMBlog

APRIL 4, 2024

Be sure to check out our previous posts on: BRONCHIOLITIS , EPIGLOTTITIS , PNEUMONIA , and CROUP The Problem: Free open access medical education (aka FOAM) is great in that it allows for asynchronous, focused learning. Our SOAR review provides readers with a curated list of high-quality blog posts on topics of respiratory infectious disease.

Education 59

Education Utilities Vaccination Provider 59

FDA Law Blog

JUNE 1, 2025

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59