FDA Law

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Combination products are sharing the digital moment with those classified solely as medical devices.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

MAY 7, 2025

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. Walsh & Sophia R. Gaulkin & Steven J. This scrutiny was enhanced after the Fourth Circuits ruling in United States v. Mallory , 988 F.3d

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Referral Relationship Government Healthcare 59

FDA Law

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

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Management Manufacturing Specialization IT 52

FDA Law

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. The CDS Guidance interprets the Cures Act’s definition of “medical software” that is excluded from the statutory “device” definition, as it relates to CDS software.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

Management 40

Management Manufacturing Specialization IT 40

FDA Law

MARCH 20, 2022

Baumhardt, Senior Medical Device Regulation Expert & Anne K. Almost all recalls are conducted on a voluntary basis by the manufacturer. Most FDA-regulated entities have an established SOP that governs the evaluation, decision, notification, and process for conducting a recall. By Philip Won & Lisa M.

Electronics 40

Electronics Manufacturing Provider IT 40

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 105

Manufacturing Management Clinical Practice Clinic 105

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. It’s not a controlled substance medication. Tasce: Yes. Taylor Swift.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

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 53

Medical Diagnosis Healthcare Clinic 53

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 PCR, nor will they perform as well in patients with a low viral load. counter (OTC) rapid antigen tests for COVID are widespread and available at low cost. Why is that? Background. 2 infection.

Screening 98

Screening Healthcare Manufacturing IT 98

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.”

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Supply Chain Manufacturing Government Hospital 59

FDA Law

JANUARY 3, 2022

Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed. The strict data requirements for tests intended to be used with asymptomatic patients led to a lack of tests available for that use. The situation now, of course, is very different and much more favorable than two years ago.

Manufacturing 52

Manufacturing IT Government Medical 52

FDA Law

JANUARY 3, 2022

Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed. The strict data requirements for tests intended to be used with asymptomatic patients led to a lack of tests available for that use. The situation now, of course, is very different and much more favorable than two years ago.

Manufacturing 52

Manufacturing IT Government Patients 52

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 59

Manufacturing Vaccination Government Diagnosis 59

FDA Law

AUGUST 14, 2022

The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D.

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Manufacturing Government Vaccination Utilities 98

GeriPal

DECEMBER 7, 2023

So if you look at government websites about heat for example, it’s got a line of buttons across the top with affected populations, outdoor workers, athletes and older people are in there. And it is going to affect, if it hasn’t already, our food quality, the food that’s available, our medications. Ruth: Right.

Healthcare 129

Healthcare IT Education Community 129

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). References 1.

Vaccination 52

Vaccination Government IT Physicals 52

FDA Law

FEBRUARY 20, 2025

Given the numerous changes in policy by the Trump administration, there had been much speculation that the government would now take a different position on this Biden-era rule. Interestingly, counsel focused his arguments exclusively on parrying legal attacks, rather than arguing why the rule was necessary to protect patients.

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102

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 59

Healthcare Professional Manufacturing Healthcare Utilities 59

FDA Law

OCTOBER 14, 2022

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “We still have a problem with COVID. The President’s comments caused us, who work in the medical product industry, to wonder how the federal government officially declares an end to the Covid-19 public health emergency. But the pandemic is over.

Medical 98

Medical Manufacturing Provider Complication 98

FDA Law

MAY 23, 2025

During the first Trump Administration, the 10-for-1 Rule seemed to be more in name only when it came to FDA, whereas this administration seems more intent on its deregulatory approach, so we expect it to have more of an impact on FDA governance this time around. specific patient populations, disease states, and procedures).

Manufacturing 59

Manufacturing Specialization IT Provider 59

Physicians News Digest

APRIL 2, 2025

By Julie Appleby Tim Winard knew he needed to buy health insurance when he left his management job in manufacturing to launch his own business. The Medical Procedure Periodic colon cancer screening is recommended for people at average risk starting at age 45 and continuing until age 75, according to the U.S. Then the bill came.

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Insurance Screening Hospital Patient-Centered 52

FDA Law

JANUARY 9, 2024

This request must provide details about, among other things: The foreign seller that will purchase the prescription drug directly from its manufacturer, along with invoices, batch, and lot/control numbers to verify the sale and the units sold. The government would require at least another 30 days to examine the shipment at the U.S.

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Supply Chain Manufacturing Chronic Condition Government 59