FDA Law Blog

NOVEMBER 6, 2022

In June 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Now, after an unfavorable HHS Office of the Inspector General (OIG) advisory opinion and two defeats in court, Pfizer has appealed the Second Circuit’s decision to the Supreme Court. Background.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law Blog

NOVEMBER 7, 2024

One less utilized method (and for good reason) to gain more certitude is the 513(g) Request for Information. By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs — In most instances, it is clear if a product will be considered a “device” under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Provider 69

Provider IT Consulting Utilities 69

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 ). Baumhardt, Senior Medical Device Regulation Expert & Adrienne R.

Medical 64

Medical Electronics Manufacturing Utilities 64

The Clinical Problem Solvers

DECEMBER 16, 2020

Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions? 13:16 Status of the current conversation on removing race from eGFR calculators: why is it so contentious? Poet Marge Piercy has written, “The work of the world is as common as mud.”

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

OCTOBER 14, 2021

Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. In this safety communication, FDA states: The U.S. 21 U.S.C. §

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

FDA Law Blog

JUNE 3, 2021

In addition, Texas recently passed HB 1033 to update its prescription drug price disclosure law that took effect in 2019. As we initially reported here , Texas enacted a law in June 2019 requiring manufacturers to submit two types of reports beginning in January 2020. A summary of these new state law developments is included below.

Manufacturing 52

Manufacturing Supply Chain Insurance Provider 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

FEBRUARY 2, 2023

Alternative methods will require significant research investment to demonstrate their utility for a particular context of use and inform regulatory decision-making. In 2019, FDA formed an agency-wide Alternative Methods Working Group indicating that it viewed the applicable scope of alternative methods to go beyond just toxicology research.

Clinic 64

Clinic IT Utilities Government 64

FDA Law Blog

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. Lax Controls Provided Employees with Opportunity to Divert. In short, the employees were provided the opportunity to not only commit the crimes but that they went undetected.

Board-Certified 52

Board-Certified Provider Government Management 52

PEMBlog

SEPTEMBER 27, 2023

. · A positive test can provide false reassurance to clinicians and caregivers. A negative test can also provide false reassurance. A negative test can also provide false reassurance. The clinical utility of respiratory viral testing in hospitalized children: a meta-analysis. for bronchiolitis and 1.5% JAMA Pediatr.

Patients 52

Patients Illness Hospital Management 52

Physician's Practice

JUNE 25, 2025

These videos are 5 to 10 minutes in length and will provide practical ideas and suggestions that have been tested in his practice or used by other physicians that significantly improve the efficiency and productivity of their medical practices. Baum is Professor of Clinical Urology at Tulane Medical School in New Orleans, Louisiana.

Patients 52

Patients Private Practice Management Healthcare 52

FDA Law Blog

JUNE 7, 2021

Subpart H) pathway in 2014, then issued it as final guidance in January 2019. It is noteworthy that this sentence that no clinical benefit has been established was deemed by FDA as unnecessary for Aduhelm to provide additional context beyond that the approval is based on reduction in amyloid beta plaques. What do we mean?

Clinic 98

Clinic IT Private Practice Utilities 98

The Clinical Problem Solvers

FEBRUARY 8, 2023

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. 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.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

The Clinical Problem Solvers

APRIL 5, 2022

Dr. Kushel and Mr. Watts remind healthcare providers to speak out about the structural causes of homelessness. Published April 5, 2019. January 18, 2019. Calac, Victor A. Our guests remind us to ask our patients about their housing status using non-judgmental and non-stigmatizing language. Can you refer your patient there? 3.

Community 52

Community Patient-Centered Emergency Room Hospital 52

FDA Law Blog

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. pricing, among other things. See 42 U.S.C. 1396r-8(b)(3)(C)(iii).

Manufacturing 59

Manufacturing Utilities Provider IT 59

GeriPal

AUGUST 25, 2022

I had looked at a research article that had recently evaluated the prevalence of private equity transactions in the hospice market and noted that there was a pretty substantial uptick in the past decade, and really over the course of say around 2015 to 2019. We’re going to be talking about each one of these papers. Is it you, Melissa?

Family 106

Family Families IT Patients 106

PEMBlog

APRIL 26, 2023

From 2019 to 2020, the rate of firearm related deaths among children increased by 30%. Studies demonstrate that utilizing one of these storage methods can reduce the suicide and unintentional gun deaths in children by up to 54%. [ Kristen ] Great question. I’m here with my co-resident, Dr. Humphrey. Thank you for hosting us, Brad!

Family 52

Family Families Mental Health Healthcare 52

FDA Law Blog

JUNE 2, 2023

For 10 high-cost single source covered outpatient drugs selected annually by CMS, manufacturers would be required to respond to a so-called “price verification survey” by providing not only clinical and utilization information about the drug, but also costs of production, distribution, research, and marketing; revenue and profit; and ex-U.S.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

BMJ

MAY 10, 2022

Immunization, 2019. Primary care visits increase utilization of evidence-based preventative health measures. Healthcare Providers’ Vaccine Perceptions, Hesitancy, and Recommendation to Patients: A Systematic Review. Two hundred seventy-six of the healthcare professionals were reached (response rate: 85.4%). BMC Fam Pract.

Vaccination 40

Vaccination Healthcare Professional Healthcare Primary Care 40

FDA Law Blog

AUGUST 21, 2023

Further, FDA has utilized a variety of strategies to call attention to safety issues through Dear Doctor letters or other forms of communication, even if directing changes to labeling is difficult. Koblitz & Deborah L. Agency officials estimated that it took at least 6 years to complete the required rulemaking process.”

Manufacturing 40

Manufacturing Consulting Healthcare Professional Vaccination 40

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

Eating fruit provides excellent health benefits and is part of a healthy plate. Fruits provide nutrients vital for health and maintenance of your body. Fiber containing foods such as fruits help provide a feeling of fullness with fewer calories. Then take a moment to reflect on your unique plate.

Referral 40

Referral Family Medicine DO Primary Care 40

FDA Law Blog

OCTOBER 29, 2023

Since that blog post, an important step forward was the decoupling of the coverage requirement from the FDA Birth Control Guide in the guidance provided by the Department to plans and issuers.

Individual 45

Individual Insurance Healthcare Provider 45

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 Provider 59

FDA Law Blog

SEPTEMBER 13, 2021

A May 2019 CMS final rule that would have required drug TV advertisements to disclose the WAC of the drug was challenged by a group of pharmaceutical companies and vacated on statutory grounds by the D.C. Medicare negotiation authority; encourage biosimilars and generic drug utilization). Last Thursday, the U.S.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98