Remove 2003 Remove Pharmaceuticals Remove Pharmacy Remove Regulations
article thumbnail

The FDA and Feasible Alternative Designs

Drug & Device Law

2003), aff’d , 810 N.Y.S.2d The court in Wolfe refused to impose a negligence duty on the defendant pharmaceutical company to develop and obtain FDA approval of the plaintiff’s non-FDA-approved alternative. In at least the short term, a popular pain reliever would have to be removed from pharmacies. 2d 839, 851 (N.Y. 2006), app.

FDA 59
article thumbnail

NPP, DCC, And FDA-Regulated Medical Products

Drug & Device Law

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A state cannot regulate commerce occurring wholly outside its borders. 644 (2003), but not to Pike. Ogden , 22 U.S. Wisconsin , 228 U.S. 115 (1913), and Savage v. 501 (1912).