Healthcare IT Today

FEBRUARY 26, 2023

billion total transactions since 2014. RapidAI received FDA 510(k) clearance for Rapid RV/LV , which helps physicians assess pulmonary embolism severity. Diagnostic testing platform ixlayer joined the BrightInsight Ecosystem of regulated medtech and biopharma products.

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HIPAA Journal

OCTOBER 21, 2022

Keith Ritson, 42, of Bayville, New Jersey, is a former pharmaceutical sales representative who promoted compound prescription medications and other drugs between 2014 and 2016. He is due to be sentenced on Feb. Alario faces up to one year in jail and a $50,000 fine for his role in the scheme.

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Health Populi

FEBRUARY 21, 2023

This has been a consistent health consumer sentiment for a long time: here’s how I covered PwC’s study on The Wearable Future back in 2014. ” As employers increasingly pay attention to worker wellness and population health, the enterprise-coverage vision that PwC began to quantify in 2014 is (finally) gaining traction.

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SQA

AUGUST 8, 2023

The rules also cover other services that perform activities related to clinical analysis examinations, such as isolated (private) offices and pharmacies, which are considered health services since the publication of Law 13.021/2014. The rules of RDC 786/2023 correspond to a normative update, which replaces RDC 302/2005.

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SQA

MAY 24, 2023

ANVISA Resumes Inspections in the Area of Technovigilance, 29 March 2023 In partnership with local Health Surveillance, ANVISA technical teams carried out in March 2023 two (2) medical device manufacturer inspections with an aim to strengthen the monitoring of these products in Brazil, ensuring their safety, performance, and quality.

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SQA

JUNE 10, 2021

ANVISA has also released a set of 106 proposals for Regulatory Projects that will compose the 2021-2023 Regulatory Agenda. Commission in March 2015 after the publication, in December 2014, of the Q3D Guideline on Elemental Impurities (EI) by the International Council for Harmonization (ICH). The deadline for comments is 30 June 2021.

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Health Law Advisor

AUGUST 1, 2023

As discussed in our June Insight , earlier this year FDA publicly announced its development of a proposed rule that would expressly define laboratory developed tests (“LDTs”) as medical devices and subject them to the agency’s regulatory authority. As a refresher, the exact contents and structure of the proposed rule remain a mystery.

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SQA

DECEMBER 16, 2022

The changes will serve to strengthen the country’s medical device registration regulations upon their effective date of 01 March 2023. 26 of 2014. The new Annex 1 will begin on 25 August 2023 with the exception that the deadline for Chapter 8.123, “Product transfer/ loading/unloading areas for lyophilizers” is 25 August 2024.

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SQA

SEPTEMBER 2, 2022

effective as of 01 July 2023. United States Food and Drug Administration (FDA) – Regulations and Guidances. FDA Proposes Benefit-Risk Considerations for Product Quality Assessments, 20 June 2022. The European Pharmacopoeia (Ph. Commission held its 173rd session on 21 and 22 June 2022. Supplement 11.2,

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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.

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SQA

FEBRUARY 26, 2024

The action was held from 26 to 28 September 2023, at the city’s international entry points. ANVISA Publishes New Measures to Prohibit Cosmetic Products Used in Injectable Form, 10 October 2023 ANVISA published two resolutions that suspended the trade, distribution, manufacture, advertising, and use of products from PHD Cosméticos Ltda.

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Bill of Health

MAY 28, 2024

Since 2014, Congress has passed spending amendments that limit the use of federal funds for enforcement against state-compliant medical marijuana programs. In August 2023, HHS sent an official recommendation to the DEA that it categorize marijuana under the less restrictive Schedule 3 category. From 2009-2018, several U.S.

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Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. 2023 WL 6216933 (S.D. 25, 2023), no court had slid all the way to the bottom of the “parallel claim” slippery slope. 2023 WL 6216933, at *5. 273, 288 (2014); PLIVA, Inc.

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Drug & Device Law

DECEMBER 4, 2023

Taking the good doctor first, In re Philips Recalled CPAP, Bi-Level Pap, & Mechanical Ventilator Products Litigation , 2023 WL 7019667 (Sp. 28, 2023) (“ CPAP I ”), addresses primarily medical monitoring. 2023 WL 7019667, at *3 (internal citations and quotation marks omitted). 2023 WL 7019667, at *11-13. Words fail us.

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Drug & Device Law

JULY 24, 2023

Nonetheless, the Ninth Circuit’s PATDC82 I allowed a RICO claim alleging that, between 1999 and 2011, defendants concealed that risk from the FDA and that, as a result, every TPP in the country paid for Actos prescriptions that it otherwise would not have reimbursed. But the FDA has concluded just the opposite. 3d 1243 (9th Cir.

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Drug & Device Law

NOVEMBER 10, 2023

That phrase echoed in our minds when we first read In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2023 WL 1818922 (D.N.J. Valsartan , 2023 WL 1818922, at *24. See Valsartan , 2023 WL 1818922, at *24 (justifying unprecedented class certifications as “promoting Class Action settlement”).

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Drug & Device Law

JANUARY 15, 2024

2021), aff’d by an equally divided court , 2023 WL 8859656 (Pa. 22, 2023) (“ Sullivan I ”), another decision not involving prescription medical products. “We conclude that evidence of compliance with industry standards is inadmissible under the risk-utility test in strict products liability cases. 2023 WL 8859656, at *9 (Pa.

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Drug & Device Law

DECEMBER 28, 2023

3d _-, 2023 WL 8711617 (S.D.N.Y. 18, 2023), is a worthy heir to the history above. After rejecting preemption at the motion to dismiss stage, the court solicited and FDA refused to provide its input on the plaintiffs’ purportedly adequate warning as to the risk of ASD and ADHD with a range of acetaminophen-containing OTC products.

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Drug & Device Law

MARCH 2, 2023

1:22-CV-00197-LMM, 2023 WL 2111346 (N.D. 17, 2023), however, left us scratching our heads. In the same month in 2014, the Supreme Court issued the Bauman decision on general personal jurisdiction and the Walden case on specific personal jurisdiction. 2023 WL 2111346, *6. The recent decision in Blevins-Ellington v.

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Drug & Device Law

MARCH 16, 2023

We have made no secret of our long-held views that “failure to withdraw” or “stop selling” theories of liability for FDA-authorized medical products are unwarranted perversions of state design defect law and preempted anyway. 2014) (Pennsylvania law), mucked things up and cases like Yates v. 1:22-cv-00141-MR, 2023 WL 2386776 (W.D.N.C.

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Drug & Device Law

JANUARY 8, 2024

In our recent post describing the best prescription medical product liability litigation decisions of 2023, no fewer than three of the opinions we discussed: #4 In re Acetaminophen-ASD-ADHD Products Liability Litigation , F. 3d , 2023 WL 8711617 (S.D.N.Y. 18, 2023), #5 Onglyza Products Cases , 307 Cal. 2023 WL 4837521 (2d Cir.

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Drug & Device Law

FEBRUARY 28, 2023

FDA regulations draw important distinctions between brand drugs and generic drugs. A manufacturer seeking FDA approval of a new drug must prove safety and efficacy involving expensive and lengthy clinical trials. 2023 WL 2090702 (N.D.Ga. Assuming defendant did provide the FDA with information, that only begs more questions.

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Drug & Device Law

NOVEMBER 2, 2023

Wells Pharma of Houston, LLC , 2023 WL 6301651 (S.D. 2023), because it rejects the use of state law to impose requirements beyond those imposed by the FDA. In general, a prescription drug must be approved by the FDA before it may be sold. 2023 WL 6301651, at *4. 2014); Caplinger v. 21 U.S.C. §

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Drug & Device Law

MAY 26, 2023

Ct. — , 2023 WL 3356528 (U.S. May 11, 2023) (“NPP”), evidences each of those old saws. We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. Politics makes strange bedfellows. So does the law. Weird cases also make weird law.

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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. . .

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