Drug Target Review

JUNE 29, 2023

It set a precedent with regulators as to what is expected in some instances. Regarding the NY-ESO programme that we worked on, I started work on that in 2002 before we even knew that we were going to do cell therapy. Numerous organisations are adopting many of the techniques we developed considering that incident.

Therapies 115

Therapies Science Production Cell Biology 115

Drug & Device Law

AUGUST 28, 2023

1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. 435, 436 (2002). The Doctors therefore sustain a concrete injury when they are forced to divert time and resources away from their regular patients. E.g. , Estee Lauder, Inc. FDA , 727 F. 1, 6 (D.D.C. Collagen Corp. , 885, 891 (N.D.

FDA 52

FDA FDA Approval Doctors Production 52

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. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. 435, 436 (2002). 16, 2023) ( Hippo III ), for our product liability clients, which are significant enough.

FDA Approval 59

FDA Approval FDA Doctors Production 59

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.

FDA Approval 52

FDA Approval FDA Doctors Government 52

Drug & Device Law

NOVEMBER 9, 2023

357 (2002); United States v. If unfettered truthful off-label promotion is permissible, then the incentives for regulated entities to spend the large amounts of time and money now required to submit new uses of already approved FDA-regulated products for additional approvals would be reduced. E.g. , Sorrell v. IMS Health Inc. ,

FDA 64

FDA Nurses Production Regulations 64

Drug & Device Law

JUNE 13, 2022

The FDA’s regulations for medical device labeling generally require that such labeling include “any relevant hazards, contraindications, side effects, and precautions.” We’ve seen a couple of decisions recently in which defendants raised the “commonly known” hazards exception for medical device labeling, so we thought we’d give it a look.

Testimonials 59

Testimonials Licensing Licensing FDA 59