FDA Law

NOVEMBER 6, 2022

In its petition filed earlier this month, Pfizer challenges HHS’s interpretation of the AKS as “staggeringly overbroad,” contrary to the congressional intent behind the AKS, and a threat to “almost any activity that facilitates patient access to federally funded healthcare.” Background.

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FDA Law

APRIL 4, 2023

By Philip Won — South Korea has made significant achievements over the years in the biohealth industry, establishing the world’s second-largest biopharmaceutical manufacturing capacity. South Korea continues to drive the effort in the biohealth industry, which will lead to more Korean players in the U.S.

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FDA Law

MAY 7, 2025

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Mallory , 988 F.3d 3d 730 (4th Cir. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th Medicare or Medicaid).

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FDA Law

JANUARY 5, 2023

The Playbook is a guide for healthcare delivery organizations to respond to cybersecurity incidents that threaten device function and, potentially, patient safety. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?

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FDA Law

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. §

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FDA Law

JUNE 15, 2022

Kirschenbaum — In 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule to significantly decrease the rate the government will reimburse 340B hospitals in 2018 for outpatient prescription drugs from average sales price (“ASP”) plus 6% to ASP minus 22.5%. By Faraz Siddiqui & Alan M. 52494 (Nov.

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Hospital Government Provider IT 52

FDA Law

MARCH 30, 2022

But if you limit a generic drug manufacturer’s ability to settle cases, that manufacturer does not settle fewer cases, it submits fewer Paragraph IV ANDAs. healthcare system. It could also address FDA’s concern about companies submitting ANDAs with non-compliant manufacturing facilities identified.

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Manufacturing IT Government Healthcare 40

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.

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GeriPal

MARCH 2, 2023

And so it pops up and if you’re a different prescriber from a different healthcare system, you can still see if people have filled it, it’s limited to the amount of fills you can get in the amount of tablets or capsules you can get in a month. We should be able to trust all the data that comes from our governing board.

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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.

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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. So the things that Karl mentioned, but also access to healthcare during a disaster or even heat. Why is it up to the healthcare system?

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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.

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FDA Law

JULY 12, 2021

Two states have submitted importation plans to FDA for approval, but the rule and the certification were promptly challenged in federal court by the Pharmaceutical Research and Manufacturers of America (PhRMA) and other interest groups. Among the Order’s mandates for DHHS are several relating to prescription drugs.

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FDA Law

MAY 26, 2025

Below, we highlight some of the challenges we would see in the governments attempt to pursue these cases. Attorneys Offices to use the False Claims Act (FCA) to investigate the submission of false claims to federal healthcare programs for non-covered services related to radical gender experimentation. Driehaus , 573 U.S.

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