2018, Medical, Patients and Utilities

Utilization of Treatment for Chlamydia and Gonorrhea in the Primary Care Setting Using the American Family Cohort [Infectious diseases (not respiratory tract)]

Annals of Family Medicine

NOVEMBER 20, 2024

Study Design and Analysis: A retrospective cohort from 2018-2022. Setting or Dataset: Electronic health records from the PRIME Registry, years 2018-2022. Intervention/Instrument: Key patient characteristics such as race/ethnicity and social determinants of health were considered. treatment rates, respectively.

Primary Care

Primary Care Family Families Utilities

How Mental Health & SUD Bias Impact ED Physical Care

Physician's Weekly

JUNE 19, 2025

Mental health and SUD bias impact the quality of ED care that patients with these conditions receive for physical health concerns, according to research. What the Patients Said According to the study, three key themes emerged: Negative encounters dominated. Isbell, PhD , of the University of Massachusetts Amherst, and colleagues.

Mental Health

Mental Health Physicals Patient-Centered Patients

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

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 ).

Patients

Patients Clinic Medical Patient-Centered

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

FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). FDA defines real-world data ( RWD ) as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.” By Jeffrey N.

Medical

Medical Clinic Patients IT

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

The Clinical Problem Solvers

DECEMBER 16, 2020

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. Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice.

Clinic

Clinic Education Clinical Practice Patient-Centered

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

FDA Law Blog

AUGUST 4, 2022

Recognizing that this out-of-pocket cost still represents a significant financial barrier for many patients, Pfizer proposed a Direct Copay Assistance Program for Medicare Part D beneficiaries using tafamidis. Further, “there is little utility in comparing the language of the BIS to that of the AKS.”. The Lesson of this Case.

Manufacturing

Manufacturing Medical Government IT

510(k) Modernization 2023

FDA Law Blog

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

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] 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 Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered

Patient-Centered Manufacturing Clinic Provider

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

FDA Law Blog

JANUARY 4, 2023

By Dara Katcher Levy — A win for patient access! 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.

Patients

Patients Provider IT Utilities

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

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. Going into patient’s homes was eye opening. They were stunned by the number of calls for lift assistance for older adults who had fallen. Carmen: Yeah.

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. On that podcast he and collaborators tested a combined patient and clinician facing communication priming intervention to promote goals of care conversations. Am I summarizing that right? 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

We see our patients and our families throughout the illness trajectory into the hospital. And maybe we should have more patient-centered conversations. 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.

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.

Healthcare Professional

Healthcare Professional Manufacturing Healthcare Utilities

Primary Care Digest

Utilization of Treatment for Chlamydia and Gonorrhea in the Primary Care Setting Using the American Family Cohort [Infectious diseases (not respiratory tract)]

How Mental Health & SUD Bias Impact ED Physical Care

Trending Sources

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

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

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

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

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

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

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

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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