2018, Clinic, Provider and Utilities

The utilization patterns and impact of the Stanford Chronic Pain Self-Management Program in Eastern Ontario, Canada [Pain management]

Annals of Family Medicine

NOVEMBER 20, 2024

Context Healthcare providers often struggle to treat patients with chronic pain. The number of participants peaked in 2018 and remained stable thereafter. Conclusions: Participation in the CPSMP resulted in a clinically meaningful increase in patient activation among patients with chronic pain.

Management

Management Utilities Referral Individual

Episode 148: Antiracism in Medicine Series Episode 4 – Dismantling Race-Based Medicine Part 2: Clinical Perspectives

The Clinical Problem Solvers

DECEMBER 16, 2020

Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice. Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality.

Clinic

Clinic Education Clinical Practice Patient-Centered

When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog

MAY 13, 2024

FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.” percent of examples.

Medical

Medical Clinic Patients IT

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

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

Patients Clinic Medical Patient-Centered

FDA’s Third Party Review Program is Ready for the Next Pandemic, not the LDT Final Rule

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

Consulting Manufacturing Utilities Provider

510(k) Modernization 2023

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

Medical Electronics Manufacturing Utilities

A Final LDT Rule in April!? Will FDA be prepared?

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

IT Medical Patient-Centered Provider

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

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

Patient-Centered Manufacturing Clinic Provider

Price Limits, Affordability Boards, Penalties, Oh My: Minnesota Enacts Sweeping Drug Pricing Reforms

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

Manufacturing Provider Consulting IT

Episode 275: Anti-Racism in Medicine Series – Episode 19 – Reframing the Opioid Epidemic: Anti-Racist Praxis, Racial Health Inequities, and Harm Reduction

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

Community Patient-Centered Mental Health Board-Certified

FDA’s Accelerated Approval of Biogen’s Aduhelm for Alzheimer’s: A Sign of Applying the Emergency Use Standard Beyond COVID?

FDA Law Blog

JUNE 7, 2021

However, the FDA guidance goes on to say in some cases, additional context is needed by specifically inserting a sentence in the indications statement that: no clinical benefit has been established. be “reasonably likely to predict” ultimate clinical benefit).

Clinic

Clinic IT Private Practice Utilities

EMS Intervention to Reduce Falls: Carmen Quatman and Katie Quatman-Yates

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

Community Transportation IT PCP

The PIE Act – A Win for Patients, Payors, and Sponsors

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

Patients Provider IT Utilities

Jumpstarting Goals of Care Convos: Erin Kross, Bob Lee, and Ruth Engelberg

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. And I think that his research was informed by his clinical practice, his clinical practice was informed by his research. So what’s changed since 2018 with Jumpstart? Erin: Mm-hmm.

Patient-Centered

Patient-Centered IT Patients Hospital

Should We Shift from Advance Care Planning to Serious Illness Communication?

GeriPal

FEBRUARY 24, 2022

Should we focus on something else, both from a clinical and a research perspective? 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. Does watching a video impact utilization to that degree?

Illness

Illness Patient-Centered IT Patients

Senator Durbin Has Questions About FDA’s “Operational Capacity” to Oversee DTC Prescription Drug Advertising Amid Workforce Reductions – Don’t We All?

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

Healthcare Professional Manufacturing Healthcare Utilities

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

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

Manufacturing Supply Chain Patient-Centered Utilities

Primary Care Digest

The utilization patterns and impact of the Stanford Chronic Pain Self-Management Program in Eastern Ontario, Canada [Pain management]

Episode 148: Antiracism in Medicine Series Episode 4 – Dismantling Race-Based Medicine Part 2: Clinical Perspectives

Trending Sources

When Worlds Collide: The Theory of Real-World Evidence Meets Reality

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

FDA’s Third Party Review Program is Ready for the Next Pandemic, not the LDT Final Rule

510(k) Modernization 2023

A Final LDT Rule in April!? Will FDA be prepared?

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

Price Limits, Affordability Boards, Penalties, Oh My: Minnesota Enacts Sweeping Drug Pricing Reforms

Episode 275: Anti-Racism in Medicine Series – Episode 19 – Reframing the Opioid Epidemic: Anti-Racist Praxis, Racial Health Inequities, and Harm Reduction

FDA’s Accelerated Approval of Biogen’s Aduhelm for Alzheimer’s: A Sign of Applying the Emergency Use Standard Beyond COVID?

EMS Intervention to Reduce Falls: Carmen Quatman and Katie Quatman-Yates

The PIE Act – A Win for Patients, Payors, and Sponsors

Jumpstarting Goals of Care Convos: Erin Kross, Bob Lee, and Ruth Engelberg

Should We Shift from Advance Care Planning to Serious Illness Communication?

Senator Durbin Has Questions About FDA’s “Operational Capacity” to Oversee DTC Prescription Drug Advertising Amid Workforce Reductions – Don’t We All?

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

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