SQA

AUGUST 8, 2023

United States Food and Drug Administration (FDA) – Regulations and Guidances Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol, May 2003 This guidance is intended to alert pharmaceutical manufacturers, compounders, (..)

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FDA Compliance COVID-19 World Health 40

Health Populi

MARCH 26, 2020

medical spending in Health Affairs in 2003. ” And, as an Artist-in-Residence, I’m creating an ABCovid Journal which, someday, I’ll feature here in the Health Populi blog. As a public health person, I’m especially drawn to bolstering my “Quaranteam.”

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COVID-19 Health Insurance Public Health Medical Billing 73

New Jersey Healthcare Blog

JULY 22, 2022

On June 20, 2022, at 54 N.J.R. 1117(a), the Department of Human Services, Office of Program Integrity and Accountability proposed amendments, repeals, and new rules to comply with the Department’s Fee-for-Service initiative, the Centers for Medicare and Medicaid Services’ guidelines for funding, Danielle’s Law, P.L. 191 (N.J.S.A.

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COVID-19 Vaccine Licensing COVID-19 Public Health 40

Bill of Health

SEPTEMBER 1, 2023

The National Health Act (2003) and its accompanying regulations apply to fertility care generally, together with the guidelines that apply to reproductive health and fertility specialists. Surrogacy is specifically regulated under the Children’s Act of 2005, which sets out the legal requirements for a valid surrogacy agreement.

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Health Insurance Public Health Doctors 157

Health Populi

MAY 28, 2023

In tomorrow’s Health Populi blog, I’ll cover the The 2003 Axios Harris Poll 100, a list of the top 100 consumer brands in the U.S.

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Health Insurance Hospitals COVID-19 62

Drug & Device Law

JULY 31, 2023

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. 2003), review denied (Cal. Bilow , 2003 WL 1475141, at *4 (Conn.

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Governance Payment Systems Hospitals Licensing 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. 2003), and Doe v. 300aa-10, et seq. Because [her] claims arise out of a vaccine-related injury, it appears her claims are subject to the [Act’s] exhaustion requirement.” Aventis Pasteur, Inc. , 559 (2d Cir.

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FDA Public Health Fraud Hospitals 115

Drug & Device Law

JANUARY 30, 2023

For those of you accessing the Blog on mobile devices, this post may be hard to read. Plaintiffs Legal Committee , 531 U.S. 341 (2001), with the rejection of the so-called “purposes and objectives” prong of implied preemption by the most conservative justices (at least in terms of federalism) on the Court. Moran , 536 U.S. Walsh , 538 U.S.

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FDA Fraud Governance Medicare 72

Drug & Device Law

FEBRUARY 20, 2023

2003), aff’d , 810 N.Y.S.2d As we’ve said many times before, the Blog does not do the other side’s research for them. Well, that’s what the Blog is here for – and that’s what prompted this post. Lederle Laboratories recognized that courts, generally, are “reluctan[t]. . . 2d 839, 851 (N.Y. 2d 506 (N.Y. 2006), app. 2d 1137 (N.Y.

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FDA Licensing Hospitals Governance 59

Drug & Device Law

APRIL 10, 2023

That’s why this defense oriented blog has inveighed against claims solely for “ medical monitoring ” ever since it was founded. 135, 156-57 (2003); Metro-North Commuter Railroad Co. Prosser & P. Keeton, Prosser & Keeton on the Law of Torts , at 165 (5th ed. Federal law : Norfolk & Western Railway Co. Ayers , 538 U.S.

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Malpractice Governance Hospitals 59

Drug & Device Law

DECEMBER 18, 2023

Like many of you, I’ve been a consistent reader of the blog for years and I rely on it regularly. I remember talking with Jim Beck and Mark Herrmann many years ago when the blog was just getting started (pretty sure it was 2006). I’m excited about contributing to the blog and welcome any comments. Now here we are.

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Drug & Device Law

MARCH 4, 2024

March 14, 2003), recognized that replacing an excluded expert “is not the way the Federal Rules of Civil Procedure work. A Vaccine Act case similarly held that “parties are expected to put their best case forward in the first instance.” Secretary of HHS , 66 Fed. 49, 55 (2005). In Rimbert v. Eli Lilly & Co. 2009 WL 10672150 (D.N.M.

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Drug & Device Law

JANUARY 17, 2022

PCMA involved something altogether outside our sandbox – express preemption under ERISA and/or the 2003 statute that created “Medicare Part D.” Long-time Blog readers may recognize both of these decisions from our first-ever blogpost on the presumption against preemption some fifteen years ago. Travelers Insurance , 514 U.S.

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Medicare Medicare 45

Drug & Device Law

JUNE 13, 2023

In the “ 50-State Survey of State Court Decisions Supporting Expert-Related Judicial Gatekeeping ,” the Drug & Device Law Blog (the Best Blog on the Planet) describes West Virginia as a “gatekeeper” state because of cases reflecting adoption of the Daubert analysis of W. 702 by the Supreme Court of Appeals of West Virginia.

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Malpractice 59

Drug & Device Law

DECEMBER 11, 2023

2003 WL 27423681, at *4 (N.D. Ohio September 4, 2003) (severing non-diverse medical malpractice defendants; “a court may perfect diversity jurisdiction by dropping a non-diverse and dispensable party at any time” and may act “on the motion of a party or sua sponte ”), reconsideration denied , 2004 WL 7384895 (N.D.

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