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

JULY 8, 2022

Food and Drug Administration (FDA) and product manufacturers are aware that it may be present in food and drug products at trace levels, and those very low levels do not pose a safety concern for consumers. Benzene is a chemical that is ubiquitous in the environment and not an intentionally added ingredient in personal care products.

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SQA

AUGUST 2, 2021

ISO 10651-4:2002, Lung ventilators – Part 4: Particular requirements for operator-powered resuscitators. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. United States Food and Drug Administration (FDA) – Guidances for Drugs and Biologics.

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Health Law Advisor

APRIL 26, 2023

FDA have called into question the U.S. Food and Drug Administration’s (“FDA’s”) scientific review process to approve new drug applications. The Texas District Court ruling had the effect of suspending the FDA’s approval of mifepristone. FDA , the FDA moved the U.S. While the U.S.

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SQA

FEBRUARY 26, 2024

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

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FDA Compliance COVID-19 Public Health 52

SQA

FEBRUARY 26, 2024

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

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Drug & Device Law

FEBRUARY 19, 2024

For both prescription drugs and medical devices, FDA regulations provide that direct-to-patient warnings – called “adequate directions for use” – are not necessary for drugs or devices that are available only with a physician’s prescription. 6551, 6553 (FDA Feb. Ortho Pharmaceutical Corp., 2d 522, 528 (Or. Griffith v. Blatt , 51 P.3d

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Drug & Device Law

JANUARY 8, 2024

The Acetaminophen MDL was a classic example, where the FDA had independently looked at the science no fewer than six times (in 2014, 2015, 2016, 2017, and 2022, and 2023) and each time concluded that the science did not justify any warning. 2002) (affirming “for the reasons stated” in the district court opinion). Amorgianos v.

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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

DECEMBER 4, 2023

2002). “[I]t is not the role of a federal court to expand state law in ways not foreshadowed by state precedent.” CPAP II shrugs off plaintiffs’ repeated allegations that defendants “failed to apprise the FDA” of this or that, with the excuse that plaintiffs don’t really “rely” on them. Ford Motor Co. , 3d 661, 680 (3d Cir.

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Drug & Device Law

NOVEMBER 9, 2023

In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here ), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog. 357 (2002); United States v. FDA , 119 F. E.g. , Sorrell v.

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Drug & Device Law

SEPTEMBER 11, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” FDA , 727 F. That’s why Buckman Co.

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Drug & Device Law

AUGUST 28, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” FDA , 727 F. That’s why Buckman Co.

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FDA Doctors Malpractice COVID-19 52

Drug & Device Law

AUGUST 7, 2023

By contrast, the Riegel preemption clause for medical devices prohibits only state-law requirements that are “different from or in addition to” FDA medical device requirements. 2002) (“Under the product liability law of California, injury to the plaintiff from a defective product is an essential element. . ., E.g. , Kanter v.

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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. In a lot of ways Pietrantoni is a pretty good case for the defendants. 2022 WL 16857262, at *8 (design claim), *11-15 (warning claim).

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Drug & Device Law

FEBRUARY 2, 2023

Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law. March 4, 2005), rev’d on other grounds , 462 F.3d 3d 364 (5th Cir. American Home Products Corp. ,

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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

JANUARY 9, 2023

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. Levine , 555 U.S. Plaintiffs Legal Committee , 531 U.S. 2022 WL 17348351, at *4. The monograph system was reformed [in 2020]. Albrecht , 139 S. 2019), and Levine.

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Drug & Device Law

NOVEMBER 10, 2022

3, 2002) (to be published), the California Court of Appeal held that federal law preempts state law failure-to-warn claims alleging that branded and generic drug manufacturers did not ensure that patients received FDA-approved Medication Guides for amiodarone, a heart medicine. In Amiodarone Cases , No. A161023, 2022 WL 16646728 (Cal.

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Drug & Device Law

JUNE 13, 2022

But in the device area – we looked, but did not find an analogous FDA regulatory exception for drugs – the FDA has itself recognized this common-sense, and common-law, exception to the duty to warn. Somewhat surprisingly, at least until recently, there hasn’t been much case law addressing the FDA’s “commonly known” hazard exception.

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Drug & Device Law

JUNE 6, 2022

The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . . Bayer HealthCare Pharmaceuticals, Inc. , 3d 1223, 1233 (11th Cir. label, he would still have prescribed [the drug] to [plaintiff]. . . .

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Drug & Device Law

APRIL 19, 2022

Not too long ago we researched precedent that forbade persons claiming to be “FDA experts” from opining that products are “adulterated” or “misbranded.” 2002) (prohibiting expert testimony on FDCA term “materially misleading”); Torres v. citations omitted). Other appellate decisions cited in Xue are: United States v. Barile , 286 F.3d

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