Clinic, Government, Manufacturing and Medical

Lots of FDA Guidance, But Few Drug Manufacturing “Remote Interactive Evaluations” (We Would Call Them “Virtual Inspections”)

FDA Law

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections.

Manufacturing

Manufacturing Clinic IT Utilities

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). products intended for medical purposes).

Medical

Medical Manufacturing Healthcare Government

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). products intended for medical purposes).

Medical

Medical Manufacturing Healthcare Government

Green Practice News: May 2025

My Green Doctor

MAY 3, 2025

In This Issue : Why Renewable Energy Belongs in Every Clinic Medical Waste: One Model for Improvement OnTrack with your Sustainability Goals? Powering Health, Protecting the Planet – Why Renewable Energy Belongs in Every Clinic Healthcare professionals have always been trusted voices on public health.

Healthcare

Healthcare Healthcare Professional Consulting Management

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

FDA Law

AUGUST 4, 2022

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. That court granted summary judgment to the government on the APA claim and rejected Pfizer’s narrower reading of the AKS, which would require an element of “corrupt” intent to impose AKS liability.

Manufacturing

Manufacturing Medical Government IT

Keeping Your Company’s Federal Contracting Options Safe in the Face of Pending BIOSECURE Act Legislation

FDA Law

MARCH 3, 2024

This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. Scope Part 2 —Is reimbursement under Medicaid a grant of funds by the federal government, such that they are governed by the Act? House of Representatives ( H.B.

Manufacturing

Manufacturing Government Consulting IT

FDA Abandons Its Defense of the LDT Rule, But is It Signaling an Increase in RUO Scrutiny?

FDA Law

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. RUO-labeled reagents and materials are often used in LDTs in clinical laboratories. By Steven J.

IT

IT Manufacturing Government Clinic

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

Clinic

Clinic Medical Provider Patients

As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

FDA Law

JANUARY 5, 2023

In mid-November, FDA collaborated with the MITRE Corporation to publish an update to the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. Combination products are sharing the digital moment with those classified solely as medical devices.

Manufacturing

Manufacturing Patient-Centered Provider Telehealth

Baby Formula Shortages

Georgetown Pediatrics & Family Medicine

MAY 11, 2022

They may have samples in stock, connections to other local organizations, or ideas of other places to call, such as your local WIC clinic. Always mix formula as directed by the manufacturer. I heard the government will be importing baby formula from other countries. I found small amounts several different formulas. Is that safe?

Supply Chain

Supply Chain Specialization IT Family Medicine

FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule

FDA Law

OCTOBER 25, 2021

The Medical Device Amendments of 1976 created the initial premarket application (PMA) review and 510(k) substantial equivalence review processes. Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. befitted a very important pathway to market for novel medical devices. FDCA § 513(f)(5).

Manufacturing

Manufacturing Specialization Government IT

‘MAHA Report’ Calls for Fighting Chronic Disease, but Trump and Kennedy Have Yanked Funding

Physician's Weekly

JULY 3, 2025

But the administration is seeking to cut government funding that could serve as a counterweight. ” Ceding Ground to Industry The MAHA report argues that corporate influence has compromised government agencies and public health through “corporate capture.” The report calls for “fearless gold-standard science.”

FDA Would Like to Join You in the Sandbox When Developing AI Enabled Devices

FDA Law

MARCH 6, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. For non-AI-enabled devices, the early feasibility research may not directly affect the development process, i.e., the final, finished device can be fully developed, transferred to a controlled manufacturing environment, and tested under a design controls process.

Manufacturing

Manufacturing Management Clinical Practice Clinic

It’s My Party and I’ll Cry if I Want to: A Bittersweet Happy 30th Birthday to LDTs

FDA Law

AUGUST 3, 2022

3, 1992) (“It has come to the attention of FDA that laboratories have been manufacturing, “home brew” products, either from products already on the market, or from components, and utilizing these unapproved products for diagnostic purposes. These products are subject to the same regulatory requirements as any unapproved medical device”).

Lab Testing

Lab Testing Government IT Manufacturing

New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

FDA Law

OCTOBER 17, 2023

Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities and to certain non-addictive medical products to treat pain or addiction. By Philip Won & Lisa M. 360e-3)).”

Medical

Medical Diagnosis Healthcare Clinic

Where Are All the OTC Rapid Antigen Tests for COVID? FDA’s Role in Blocking These Tests from the American Market

FDA Law

NOVEMBER 18, 2021

Rapid tests for COVID-19 are fast, inexpensive to manufacture, and a relatively easy method to detect the presence of an active SARS?CoV?2 This capacity limitation does not apply to OTC lateral flow antigen tests, which can be manufactured in the hundreds of millions per month at a much lower cost than RT?PCR Why is that? Background.

Screening

Screening Manufacturing Healthcare IT

Does the Drug Shortage White Paper Fall Short?

FDA Law

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”

Supply Chain

Supply Chain Manufacturing Government Hospital

Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

MARCH 2, 2023

It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US. In psychiatry, a lot of the anti-epileptic medications, we call them mood stabilizers and are used in bipolar disorder. Eric: Are these generic? Nisha: Both of them are generic, yeah.

Patient-Centered

Patient-Centered IT Healthcare Medical

The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law

JUNE 4, 2025

Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

Chronic Disease

Chronic Disease Government Chronic Condition Clinic

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

FDA Law

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers.

Manufacturing

Manufacturing Vaccination Government Diagnosis

Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

DECEMBER 7, 2023

AlexSmithMD Additional links: JAMA paper on clinical research risks, climate change, and health Geriatric medicine in the era of climate change Health Care Without Harm: [link] Practice Green Health: [link] Global Consortium for Climate and Health Education: [link] Transcript Eric: Welcome to the GeriPal podcast. Ruth: Right. Ruth: Yeah.

Healthcare

Healthcare IT Education Community

Arsenicum album for Kerala school students: a bogus prophylaxis

Tiny Physician

OCTOBER 17, 2021

The Kerala government has taken off all the restrictions imposed due to the case surge as caseload has come down, and is also planning to restart schools from the second half of November. Indian Medical Association (IMA) Kerala wing criticized the minister at that time as the medicine lacked scientific evidence (2).

Vaccination

Vaccination Government Physicals IT

Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

FDA Law

FEBRUARY 20, 2025

On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services. In contrast, AMP and ACLA both asserted that the rule would harm medical care.

Patient-Centered

Patient-Centered Consulting Government Clinic

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. In 2021, the U.S.

Healthcare Professional

Healthcare Professional Manufacturing Healthcare Utilities

Primary Care Digest

Lots of FDA Guidance, But Few Drug Manufacturing “Remote Interactive Evaluations” (We Would Call Them “Virtual Inspections”)

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

Trending Sources

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

Green Practice News: May 2025

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

Keeping Your Company’s Federal Contracting Options Safe in the Face of Pending BIOSECURE Act Legislation

FDA Abandons Its Defense of the LDT Rule, But is It Signaling an Increase in RUO Scrutiny?

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

Baby Formula Shortages

FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule

‘MAHA Report’ Calls for Fighting Chronic Disease, but Trump and Kennedy Have Yanked Funding

FDA Would Like to Join You in the Sandbox When Developing AI Enabled Devices

It’s My Party and I’ll Cry if I Want to: A Bittersweet Happy 30th Birthday to LDTs

New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

Where Are All the OTC Rapid Antigen Tests for COVID? FDA’s Role in Blocking These Tests from the American Market

Does the Drug Shortage White Paper Fall Short?

Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

The MAHA Assessment’s Implications: Drugs (Part One)

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

Arsenicum album for Kerala school students: a bogus prophylaxis

Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

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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