Drug & Device Law

JANUARY 12, 2024

The FDA approved the defendant’s first TDF drug in 2001, and the company started its first clinical trial on a different compound—tenofovir alafenamide (“TAF”)—about a year later. The court also assumed that physicians naturally would prescribe the “newer” TAF once the FDA approved it. at *48-*50. at *31, *32.

FDA Approval 105

FDA Approval Drugs Production FDA 105

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). & Com.

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. FDA , 727 F.

FDA 59

FDA FDA Approval Clinical Trials Pharmaceuticals 59

Drug & Device Law

OCTOBER 10, 2023

Each claim alleges that defendants’ failure to comply with FDA’s regulations is an unfair business practice and/or causes “consumer confusion.” That’s the FDA’s job, not the court’s. 341 (2001). Finding non-disclosure different than, for example, a claim premised on false assertions of FDA approval.

FDA Approval 59

FDA Approval FDA Pharmacy Regulations 59

Drug & Device Law

SEPTEMBER 22, 2023

Constitution’s Supremacy Clause, it strikes a balance between state and federal power on issues of public health and safety, and raises questions about whether our country’s approach to regulation and litigation makes sense for pharmaceuticals and medical devices (spoiler alert: it doesn’t). 379r(a)(1). 379r(a)(1). 379r(a)(1). at 1281-82.

Drugs 105

Drugs Regulations Production FDA Approval 105

Drug & Device Law

SEPTEMBER 18, 2023

The ASR program was initially open to regulated manufacturers of twelve device categories; Intravascular (I.V.) FDA, CDER, “Guidance for Industry − Medical Device Reporting − Alternative Summary Reporting (ASR) Program, 2000 WL 34503093, at *1 (Oct. 341 (2001). an exemption from the individual event reporting requirements.”

FDA 59

FDA Regulations FDA Approval Production 59

Drug & Device Law

SEPTEMBER 11, 2023

In our line of work, much of what we do depends on the continuing validity of how the FDA regulates prescription medical products. 341 (2001), is so important. It prevents plaintiffs in prescription medical product liability litigation from making collateral attacks on in-force FDA decisions. FDA , 727 F.

FDA Approval 59

FDA Approval FDA Doctors Production 59

Drug & Device Law

AUGUST 28, 2023

In our line of work, much of what we do depends on the continuing validity of what the FDA does with respect to prescription medical products. 341 (2001), is so important. It prevents plaintiffs in prescription medical product liability litigation from making collateral attacks on in-force FDA decisions. FDA , 727 F.

FDA 52

FDA FDA Approval Doctors Production 52

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. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

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. Jones , 225 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

Then, the decision makes a hash of the relevant administrative record, ignoring what the preemptive FDA regulations said in favor of material from the Federal Register that never actually made it into the regulations themselves. The FDA also promulgated an acetaminophen-specific OTC regulation. 201.326(a)(1).

Regulations 59

Regulations FDA Nurses FDA Approval 59

Drug & Device Law

DECEMBER 30, 2022

When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications. An unfortunate fiction developed post- Buckman —particularly after Riegel v.

FDA 59

FDA Regulations FDA Approval Production 59

Drug & Device Law

SEPTEMBER 29, 2022

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.” Once approved, a biologics label generally may not be changed without prior FDA approval. 341 (2001). Albrecht , 139 S.

FDA 59

FDA FDA Approval Licensing Licensing 59

Drug & Device Law

MARCH 10, 2022

341 (2001), impliedly preempts claims based on California’s Sherman Act, which adopts the FDCA as state law. The problem for plaintiffs is that the FDCA’s implementing regulations explicitly permit use of the indirect measurement method. A few weeks ago, we reported on Chong v. Kind LLC , 2022 WL 464149 (N.D. 2022 WL 390815, at *3.

Regulations 52

Regulations FDA Packaging FDA Approval 52