2018, Clinic, Medical and Utilities

Utility of HANDOC and CH-A in Endocarditis Triage

Physician's Weekly

JUNE 28, 2025

Medical records were reviewed to classify each episode using the HANDOC score, CH-A, and Duke-ISCVID criteria. The results showed that 325 episodes of 308 individuals with NBHS BSIs were analyzed. The TEE was utilized in 26% of cases. A total of 21 episodes (6.5%) fulfilled the duke-ISCVID criteria for definite IE.

Utilities

Utilities Clinical Practice Individual Complication

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

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.” By Jeffrey N. 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

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ). Valentine & Larry J.

Patients

Patients Clinic Medical Patient-Centered

Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law

AUGUST 4, 2022

In September 2020, the Agency issued an unfavorable advisory opinion to Pfizer, concluding that the proposal was “highly suspect” under the AKS “because one purpose of the [proposed program]—perhaps the primary purpose—would be to induce Medicare beneficiaries to purchase [Pfizer’s] federally reimbursable Medications.”

Manufacturing

Manufacturing Medical Government IT

510(k) Modernization 2023

FDA Law

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

Medical

Medical Electronics Manufacturing Utilities

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

FDA Law

DECEMBER 16, 2024

Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. The Agency has reportedly been trying to improve the program, as we discussed in 2018 and 2020.

Consulting

Consulting Manufacturing Utilities Provider

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

FDA Law

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] 11] In fact, in Fiscal Years 2018 – 2022, fewer than 100 510(k)s went through the Third-Party Review Program annually. [12] of 510(k) decisions, respectively. [13]

IT

IT Medical Patient-Centered Provider

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

FDA Law

SEPTEMBER 20, 2021

STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs. The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries.

Patient-Centered

Patient-Centered Manufacturing Clinic Provider

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

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

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

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

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

FDA Law

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

Patients Provider IT Utilities

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

GeriPal

FEBRUARY 15, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Community

Community Transportation IT PCP

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 Hospital Patients

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

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

Healthcare Professional Manufacturing Healthcare Utilities

Primary Care Digest

Utility of HANDOC and CH-A in Endocarditis Triage

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

Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

510(k) Modernization 2023

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

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

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?

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

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

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?

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