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.

Vaccine 59

Vaccine FDA FDA Approval Production 59

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.,

FDA 59

FDA FDA Approval Clinical Trials Pharmaceuticals 59

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. ,

FDA Approval 59

FDA Approval FDA Pharmacy Regulations 59

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.

FDA 59

FDA Regulations FDA Approval Production 59

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.” 341 (2001), is so important.

FDA Approval 59

FDA Approval FDA Doctors Production 59

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in design; they are not claiming that the drug warnings were inadequate; they are not claiming that TDF drugs should be withdrawn from the market; and they agree that TDF drugs have benefited and continue to benefit thousands of patients.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.

Production 64

Production Marketing Drugs Pharma Companies 64

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.” 341 (2001), is so important.

FDA 52

FDA FDA Approval Doctors Production 52

Drug & Device Law

JULY 24, 2023

What’s worse, the fraud on the FDA claim, if brought under state law, would be preempted by Buckman Co. 341 (2001). The unstated premise here was fraud on the market – an assumption that every class member always has perfect information. Plaintiffs Legal Committee , 531 U.S. You can see where this is going.

Testimonials 52

Testimonials Pharmacy FDA Doctors 52

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. . .

FDA 59

FDA FDA Approval Testimonials Vaccine 59

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.

FDA 72

FDA Regulations Production Government 72

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).

Regulations 59

Regulations FDA Nurses FDA Approval 59

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.

FDA 59

FDA FDA Approval Licensing Licensing 59

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.

Government 52

Government Production FDA Approval FDA 52