FDA Law Blog

DECEMBER 16, 2024

The final guidance appears not to make any meaningful changes that are actually likely to support or incentivize its increased utilization, which is disappointing, although not unsurprising. The guidance also addresses FDAs obligation to provide considerations on third party compensation, information sharing, and conflicts of interest.

Consulting 52

Consulting Manufacturing Utilities Provider 52

FDA Law Blog

JULY 7, 2022

The first was to develop labeling beyond the DFL and the second was to propose “additional conditions that a consumer must fulfill” with the examples self-selection tests utilizing a mobile app or a requirement for the consumer to affirm they have watched a video or read text about use of the drug.

Utilities 52

Utilities Healthcare Professional Provider IT 52

FDA Law Blog

SEPTEMBER 11, 2023

More recently, in 2019, FDA announced a push for predicate modernization ( link ) following a 2018 plan to modernize the 510(k) program by eliminating use of old predicates, sunsetting older predicates, and establishing the Safety and Performance Based Pathway ( link ).

Medical 64

Medical Electronics Manufacturing Utilities 64

The Clinical Problem Solvers

DECEMBER 16, 2020

Our esteemed publications should ensure that investigations that utilize racial variables follow these guidelines before being published. September 12, 2018. Examining the Potential Impact of Race Multiplier Utilization in Estimated Glomerular Filtration Rate Calculation on African-American Care Outcomes. link] Tsai J.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

FEBRUARY 28, 2022

The Agency’s goal is demonstrated in its definition of patient engagement: “Patient engagement is defined as intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” .

Patients 52

Patients Clinic Medical Patient-Centered 52

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

In September 2018, FDA took its first step towards electronic 510(k) submissions with its Quality in 510(k) Review Program Pilot, which we blogged about here. 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

JUNE 16, 2023

The statement must itemize the cost components related to production of the drug, identify increases in materials or manufacturing costs, and provide other information that the manufacturer believes relevant to determining whether a violation has occurred. SF 2744 also provides a private right of action to enforce the prohibition.

Manufacturing 45

Manufacturing Provider Consulting IT 45

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. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 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.

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Community Transportation IT PCP 114

The Clinical Problem Solvers

FEBRUARY 8, 2023

A more Western perspective on health care emphasizes the role of physicians and health care providers and marginalizes the role and contributions of doulas and midwives. Dr. Jordan then questions the utility and continued operation of methadone clinics, especially as the United States largely moves on from the COVID-19 pandemic.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

FDA Law Blog

JANUARY 4, 2023

The provision amends the Federal Food, Drug, and Cosmetic Act section 502 to provide explicit protection for conveying certain information about products in development to payors, including unapproved uses of approved products. 2617, the “ Consolidated Appropriations Act, 2023 ,” was signed into law by President Biden on December 29.

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 Patients Hospital 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. They’re looking at difficult outcomes, utilization outcomes, right? Does watching a video impact utilization to that degree? Rachelle: Yeah.

Illness 98

Illness Patient-Centered IT Patients 98

PEMBlog

APRIL 4, 2024

But there are some challenges when it comes to the utilization of FOAM: – Decentralization of FOAM resources – Concerns about the quality of information being presented The Solution: The Systematic Online Academic Resource, or SOAR, review was created in an effort to address some of these limitations. How can I use these findings?

Education 59

Education Utilities Vaccination IT 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. In 2021, the U.S.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59

FDA Law Blog

SEPTEMBER 13, 2021

In 2018, Trump’s Department of Health and Human Services (HHS) released its Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs , but the edifice envisioned by the Blueprint largely failed to materialize. Medicare negotiation authority; encourage biosimilars and generic drug utilization).

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98