Healthcare IT Today

JANUARY 3, 2024

The HIPAA Security Rule was drafted in 2003 and has not been substantively updated since that time. Cybersecurity is a known concern and is imperative for getting your medical device to market, especially considering the FDA’s new guidance in 2023. Health care organizations generally use other more sophisticated frameworks (e.g.,

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SQA

AUGUST 8, 2023

Personal Care Products Council (PCPC) PCPC MoCRA Toolkit, May 2023 Enacted in December 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents years of efforts by the Personal Care Products Council, the FDA, Congress, and other stakeholders to modernize the U.S. cosmetic regulatory framework.

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SQA

AUGUST 8, 2023

Personal Care Products Council (PCPC) PCPC MoCRA Toolkit, May 2023 Enacted in December 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents years of efforts by the Personal Care Products Council, the FDA, Congress, and other stakeholders to modernize the U.S. cosmetic regulatory framework.

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SQA

AUGUST 1, 2024

Consequently, the Inspection Review Group at the MMA decided to issue a Statement of Non-Compliance with the principles and guidelines of GMP laid down in Directive 2003/94/EC for the site, reflecting ongoing concerns about compliance and quality management at Cubit Lifesciences. Science and safety are at our core.

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HIPAA Journal

APRIL 5, 2023

The page reveals that, since 2003, the agency has received more than 300,000 complaints alleging violations of HIPAA. To the Federal Drug Administration to report adverse events and track FDA-regulated products. To personal representatives of adult patients and unemancipated minor patients.

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Bill of Health

MARCH 5, 2025

Food and Drug Administrations (FDA) new proposed rule on a front-of-package nutrition label, called a Nutrition Info box. From 1941 to the 1970s, FDA recommended food labels be used only for food products designed for special diets to treat physical and pathological conditions. This is the driving motivation behind the U.S.

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Drug & Device Law

JANUARY 26, 2024

Medical products based on human tissue have been around for a long time, and they are regulated by the FDA. The plaintiff shrewdly pointed out that the Illinois statute applied only to “services” or “service providers,” whereas the FDA and NIH have labeled the Defendant’s tissue-based bone repair compound as a “product.”

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Drug & Device Law

JANUARY 4, 2024

That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original).

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Drug & Device Law

NOVEMBER 16, 2023

GlaxoSmithKline , 2023 IL App (1st) 221666 (2003). The plaintiff seeking JAMA’s communications suspected that the official was someone at FDA given the article’s subject matter and the agency’s known critique of the original version’s underlying methodology. The court granted the motion and JAMA appealed.

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Drug & Device Law

MAY 26, 2023

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. A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications.

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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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Drug & Device Law

FEBRUARY 13, 2023

Those allegations, Pietrantoni held, sufficed to state an unpreempted (because the PAC program was apparently not FDA required) claim for negligent performance of a voluntarily assumed duty. 2003) (internal quotations omitted) (emphasis added). In a lot of ways Pietrantoni is a pretty good case for the defendants.

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Drug & Device Law

JANUARY 30, 2023

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

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Drug & Device Law

DECEMBER 12, 2022

2003), and Doe v. Nothing in DeCostanzo suggests that the defendant’s vaccine lacked whatever warnings the FDA had approved, and the likelihood that the FDA would give these antivaxxers the time of day on any violation claim is minimal. DeConstanzo , 2022 WL 17338047, at *4 (citing Laughter v. Aventis Pasteur, Inc. ,

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Drug & Device Law

APRIL 18, 2022

at *3 – which means, as we’ve discussed before , a manufacturer cannot include warnings about such off-label uses absent specific FDA approval. 2003 WL 1785795, at *13 (D. Apparently, the “no warnings” issue arose because physician in Rennick put the product to an off-label use, id. 3d 203 (5th Cir. 2008); Herzog v. Arthrocare Corp.

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Drug & Device Law

MARCH 28, 2022

In a recent post , we discussed a decision that, among other things, excluded an FDA expert’s “opinion” that the defendant’s medical device was “adulterated” and/or “misbranded.” Here, we’re focusing on expert opinions misusing these FDA terms of art. In Robinson v. Ethicon, Inc. 2022 WL 614919 (S.D. of Bexis’ book. In Sadler v.

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