Drug & Device Law

JANUARY 9, 2023

341, 352 (2001) (“neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles”). The FDA also promulgated an acetaminophen-specific OTC regulation. Plaintiffs Legal Committee , 531 U.S. 2022 WL 17348351, at *4. The monograph system was reformed [in 2020]. 201.326(a)(1).

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Drug & Device Law

OCTOBER 20, 2023

FDA/Alliance for Hippocratic Medicine v. LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone , a pharmaceutical FDA-approved for use in the termination of pregnancy to ten weeks, in combination with misoprostol. Danco Labs.,

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Drug & Device Law

MARCH 31, 2022

In other words, the generic manufacturers are not allowed to change the FDA-approved label. 1995) (“the deceptive practice must occur in the sale or offer for sale to consumers,” not “entirely during the marketing of the [product]”); Penn-Plax, Inc. 2001) (“irrespective of the theory of recovery. . . E.g , Morris v.

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Drug & Device Law

JANUARY 30, 2023

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. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S.

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Drug & Device Law

SEPTEMBER 1, 2023

As a result, they are not claiming a defect in design; they are not claiming that the drug warnings were inadequate; they are not claiming that TDF drugs should be withdrawn from the market; and they agree that TDF drugs have benefited and continue to benefit thousands of patients. So the plaintiffs pivoted. Superior Court , 44 Cal.

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Drug & Device Law

SEPTEMBER 18, 2023

FDA, CDER, “Guidance for Industry − Medical Device Reporting − Alternative Summary Reporting (ASR) Program, 2000 WL 34503093, at *1 (Oct. Medical device manufacturers could “request[ FDA] approval to participate in the ASR program.” Id. 341 (2001). at 501 But there are exceptions. Plaintiffs Legal Committee , 531 U.S.

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Drug & Device Law

JANUARY 4, 2024

The Complaint further alleges that data collected and submitted in support of full (as opposed to emergency use) FDA approval demonstrated the misleading nature of earlier statements. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original). Health & Safety C.

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Drug & Device Law

SEPTEMBER 29, 2022

Before a biologic may be marketed, the manufacturer must obtain a license from the FDA. Approval of an application “constitute[s] a determination” by the FDA “that … the product meet[s] applicable requirements to ensure the continued safety … of such products.” 341 (2001). See 42 U.S.C. § See 21 C.F.R.

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Drug & Device Law

FEBRUARY 11, 2024

Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. Biased litigants (and equally biased judges) cannot be allowed to second-guess FDA product determinations. Buckman Co.

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Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” 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

JANUARY 12, 2024

At issue was whether a product manufacturer could be liable to patients taking one drug for failing to bring a different, but allegedly safer drug to market sooner than it actually did. Instead, the plaintiffs claimed that the defendant should have developed and marketed a different drug sooner. Gilead Life Sciences, Inc. at *31-*32.

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Drug & Device Law

OCTOBER 10, 2023

341 (2001). 2013), the court held that plaintiff could not “bring a claim that rests solely on the non-disclosure to patients of facts tied to the scope of [FDA] approval.” Finding non-disclosure different than, for example, a claim premised on false assertions of FDA approval. Plaintiffs’ Legal Comm. ,

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