Innovaare Compliance

MARCH 1, 2022

in 2022, which is partly offset by a cost-of-living increase of 5.9% The premium increase in 2022 was widely known to be attributable to the potential use of the Alzheimer drug, Aduhelm™ (aducanumab) by Medicare beneficiaries. [2] The monthly premium for Medicare Part B rose 14.5%, from $148.50 in 2021 to $170.00

Medicare 52

Medicare Medicare Overpayments Overpayment 52

Healthcare Law Blog

AUGUST 3, 2022

is a reminder that the government will use the FCA to target medical device manufacturers for off-label use of medical devices, even where healthcare providers have decided the use is safe and effective. The FDA even required warnings on the probes’ packaging, “restricted for single person use only,” and “[d]o not re-use.”.

Governance 52

Governance FDA Medicare Medicare 52

SQA

MAY 24, 2023

Following the draft consultation in November 2022, the NMPA announced the issuance of the Regulations on the Supervision and Management of Enterprises Implementing the Main Responsibility for the Quality and Safety of Medical Devices , which will come into force on 01 March 2023.

FDA 40

FDA Licensing Governance Compliance 40

SQA

OCTOBER 18, 2023

National Medical Products Administration (NMPA) China GLP Certification Regulation Takes Effect, 01 July 2023 After consulting on the draft in 2022, the NMPA issued the Administrative Measures for Drug Good Laboratory Practice (GLP) Certification earlier this year.

FDA 40

FDA Compliance Licensing World Health 40

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

OCTOBER 18, 2022

SQA Regulatory Surveillance Summary for July and August 2022. Counterfeit COVID-19 Antigen Rapid Test Kits Found in Ontario, 05 August 2022. Unauthorized Health Products Seized from Productos Latinos El Aguila in Leamington, Ontario, 05 August 2022. Addendum to S1B Reaches Step 4 of the ICH Process, 15 August 2022.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 Compliance 40

Hall Render

APRIL 14, 2023

NATIONAL 94% of Organizations Experienced a Cyberattack in 2022 AHA blog: Strengthening crisis management in rural health care Biden signs bill ending Covid-19 national emergency Cancer drug shortages are creating dire circumstances for some patients CMS Releases FY24 IPPS Proposed Rule, Seeks to Boost Rates by 2.8%

Nursing Homes 40

Nursing Homes US Department of Health and Human Services Nurses COVID-19 40

SQA

FEBRUARY 26, 2024

Ltd, a Contract Research Organization (CRO) in Kharadi, India, was subject to a Good Clinical Practice (GCP) inspection in November 2020 and November 2022 by the Spanish Agency for Medicines and Medical Devices (AEMPS). More than ever, businesses today need a framework to guide them on their AI journey.

FDA 52

FDA Compliance COVID-19 Public Health 52

Healthcare Law Blog

APRIL 14, 2023

Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Following the U.S.

FDA 52

FDA Governance 52

Health Law Advisor

JULY 21, 2023

Food and Drug Administration (FDA) as breakthrough devices. [1] 5] However, devices in earlier stages of the FDA approval process often lack the clinical evidence needed to satisfy the “reasonable and necessary” criteria to justify CMS’s establishment of a national coverage standard.

FDA 52

FDA Medicare Medicare Patient Advocacy 52

Hall Render

MARCH 16, 2022

On Tuesday, March 15, 2022, President Biden signed into law the Consolidated Appropriations Act of 2022 ( H.R. 2471 ) that funds the federal government for the remainder of FY 2022. An overview of the FY 2022 funding bill and a summary of its health care-related provisions can be found below.

COVID-19 40

COVID-19 Medicare Medicare FDA 40

Healthcare Law Blog

JUNE 15, 2023

Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. May 17, 2023 : The Fifth Circuit heard oral arguments from the FDA, Danco, and the Plaintiffs. Had the U.S.

FDA 52

FDA Governance Telemedicine Licensing 52

Drug & Device Law

OCTOBER 10, 2022

The drug at issue was an FDA-recognized breakthrough drug that treats a relatively rare, but invariably fatal, condition – transthyretin amyloid cardiomyopathy (“ATTR-CM”). 2370 (2022), which the Blog recently wrote about here. United States HHS , 42 F.4th 4th 67 (2d Cir. A little background is in order. Pfizer , 42 F.4th

Medicare 52

Medicare Medicare FDA Prescription Drug Pricing 52

Drug & Device Law

DECEMBER 12, 2022

Some of us on the Blog are veterans of the original vaccine wars – those that preceded the enactment of the Vaccine Act, 42 U.S.C. GlaxoSmithKline PLC , 2022 WL 17338047 (E.D.N.Y. 29, 2022), which (if allowed to stand) imperils everything that Congress and the Supreme Court accomplished through the Vaccine Act. Merck & Co.

FDA 115

FDA Public Health Fraud Hospitals 115

Drug & Device Law

DECEMBER 27, 2022

What follows is from the non-Dechert side of the Blog. 3d , 2022 WL 17480906 (S.D. 2022 WL 17480906, at *1. 2022 WL 17480906, at *2 (emphasis added). The FDA recognized these results as bogus, “conclud[ing] that. . . 3d 1152 (S.D. 702, and summary judgment entered. Lab Rats – Or at Least A Ratty Lab.

FDA 59

FDA World Health Governance 59

Drug & Device Law

APRIL 28, 2022

This past weekend, there was an NCAA Division I clash of athletic teams ranked #5 and #7, respectively, that included two children of two different authors of this Blog. State and local government entities from very different parts of the country might want leeway in regulating things like the volume or time of demonstrations.

FDA 59

FDA Governance 59

Drug & Device Law

JANUARY 9, 2023

The flimsy decision in In re Acetaminophen − ASH-ADHD Products Liability Litigation , 2022 WL 17348351 (S.D.N.Y. 14, 2022), leaves us scratching our heads. 555 (2009), a prescription drug preemption case, despite the relevant drug(s) being over-the-counter (“OTC”), and thus approved under an entirely different FDA regulatory process.

FDA 59

FDA Governance Nurses 59

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

MARCH 18, 2022

This post is from the non-Winston & Strawn side of the blog. 2022 WL 715494 (5 th Cir. 9, 2022) an unreported decision out of the Fifth Circuit, is the affirmance of a trial court case that made both our PMI Preemption Scorecard and our Twiqbal cheat sheet. No such magic resurrects plaintiff’s claims in today’s case.

FDA 52

FDA Governance Hospitals 52

Drug & Device Law

JUNE 22, 2022

This is called the Drug and Device Law blog, but every once in a while we discuss cases that involve neither drugs nor devices. Still, we learned that the FDA regulated nutraceuticals with a somewhat light touch. They are governed by an almost entirely different set of legal practices and procedures. 2022 WL 1787160 (N.Y.

Fraud 59

Fraud FDA Governance 59

Drug & Device Law

MARCH 31, 2022

This post is from the non-Dechert side of the blog. GlaxoSmithKline, LLC , 2022 WL 537004 (Md. 2022 WL 53700, at *3. The Court accurately perceived the issue as “not.simply a question of creating a new liability in the nature of a tort,” but rather one of “fiscal policy” and what branch of government properly sets such policy.

Governance 52

Governance FDA Doctors Hospitals 52

Drug & Device Law

JUNE 27, 2022

This post is from the non-Dechert side of the blog. June 6, 2022), in which the court denied the plaintiff’s motion for new trial and affirmed multiple helpful rulings on the admissibility and inadmissibility of FDA-related evidence. We have blogged about Africano three times before. Africano , 2022 U.S.

FDA 52

FDA Governance Compliance 52

Drug & Device Law

FEBRUARY 24, 2022

341 (2001), stands for the proposition that only the federal government may enforce the Food, Drug, and Cosmetic Act and that any state-law claim that depends on the existence of the FDCA is impliedly preempted by 21 U.S.C. § 3d —-, 2022 WL 464149 (N.D. 2022), rejected that sophistry. 2022 WL 464149, at *1.

FDA 72

FDA Governance Fraud 72

Drug & Device Law

NOVEMBER 3, 2022

This post is from the non-Reed Smith side of the blog. Pizzitola I , 2022 U.S. As such, they are not governed by the same regulatory scheme as manmade products. He was not allowed to testify regarding adverse event reporting or defendants’ compliance with FDA requirements. Pizzitola II , 2022 U.S. 7, 2022).

FDA 59

FDA Governance Compliance 59

Drug & Device Law

JUNE 13, 2022

Now, we’ve blogged before that a similar exception exists under many states’ common law that a warning need not tell physicians how to practice medicine in order to be “adequate.” In the FDA regulatory context, United States v. 2022 WL 970681 (N.D. March 31, 2022); Robinson v. 3d , 2022 WL 614919 (S.D.

FDA 59

FDA Licensing Doctors Nurses 59

Drug & Device Law

SEPTEMBER 28, 2022

This post is from the non-Reed Smith side of the blog. 2022 WL 4295402 (E.D. 15, 2022) reads. Next, the court explains why it can take judicial notice of two PMA approval letters from the FDA. A device can fail without violating an FDA safety standard. Abbott Laboratories, Inc. And, because defendants asked.

FDA 59

FDA Governance 59

Drug & Device Law

JUNE 15, 2022

It appears intended to codify FDA regulatory authority over in vitro chemical tests, and is not the kind of thing we would ordinarily concern ourselves with on this Blog. Subsection (a) shall not be construed to affect the authority of a State, Tribal, or local government—. “(1) b) Exceptions.—Subsection b) Exceptions.—Subsection

FDA 52

FDA Governance Licensing Compliance 52

Drug & Device Law

FEBRUARY 6, 2023

One of 2022’s top-ten cases , In re Zantac (Ranitidine) Products Liability Litigation , F. 3d , 2022 WL 17480906 (S.D. 6, 2022), opened with a 4-page critique of the shortcomings of the product testing conducted by a purportedly “independent” laboratory that touched off that massively meritless MDL litigation.

FDA 59

FDA Governance 59

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

FDA 59

FDA Licensing Hospitals Governance 59