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 52

Patients Clinic Medical Patient-Centered 52

The Clinical Problem Solvers

DECEMBER 16, 2020

19:05 Clarifying the “ethics vs science” argument and critiquing research techniques 22:00 Resurgence of race-based speculation in COVID-19-related research 25:57 Implantation of ideas about innate racial inferiority within medicine 28:32 Will removal of race from algorithms potentially harm our patients?

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

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.

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Manufacturing Medical Government IT 98

FDA Law Blog

SEPTEMBER 11, 2023

This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway. In a statement released at the time, CDRH Director Jeffrey Shuren, M.D.,

Medical 64

Medical Electronics Manufacturing Utilities 64

Annals of Family Medicine

NOVEMBER 20, 2024

Setting or Dataset: American Family Cohort, a data asset including electronic health records of 8 million patients from family practices across 50 US states. Population Studied: Patients with ≥1 visit between January 2018 and December 2019 and who remained in the cohort until at least May 2020. 95% CI 0.51, 0.7)

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Primary Care Patients Diagnosis Family Practice 130

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 69

IT Medical Patient-Centered Provider 69

FDA Law Blog

JUNE 16, 2023

The Board is not required to identify all drugs that meet the above criteria and may, in consultation with the advisory council and the commissioner of health, identify drug products that fall outside these criteria but otherwise could create “significant affordability challenges” for Minnesota’s healthcare system or Minnesota patients.

Manufacturing 45

Manufacturing Provider Consulting IT 45

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 52

Patient-Centered Manufacturing Clinic Provider 52

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.

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Patients Provider IT Utilities 64

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. It was eyeopening to see patients in their own home. And so that really triggered my interest.

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Community Transportation IT PCP 114

The Clinical Problem Solvers

FEBRUARY 8, 2023

Ashley delineates that methadone has been disproportionately prescribed in predominantly Black communities, as a means to drive down crime, whereas white patients undergoing substance use treatment are more likely to receive buprenorphine.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

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 83

Patient-Centered IT Patients Hospital 83

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.

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Illness Patient-Centered IT Patients 98

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).

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Manufacturing Supply Chain Patient-Centered Utilities 98