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- Title
Too Good To Last? Will the FDA'S Proposed Rule Put an End to Generic Drug Preemption Under Mensing and Bartlett?
- Authors
Diab, Tony M.
- Abstract
The article focuses on rules of the Food and Drug Administration (FDA) for preempting claims arising out of generic drug labels. Topics discussed include FDA rules allowing generic drug manufacturers participating in the changes being effected (CBE) process, judicial opinion of the U.S. Supreme Court on the case PLIVA Inc. v. Mensing, and the importance of proper language of warning labels of the reference listed drug.
- Subjects
UNITED States. Food &; Drug Administration; GENERIC drug laws; DRUG labeling laws; JUDICIAL opinions; PLIVA Inc. v. Mensing (Supreme Court case); WARNING labels; LAW
- Publication
Defense Counsel Journal, 2015, Vol 82, Issue 1, p28
- ISSN
0895-0016
- Publication type
Article
- DOI
10.12690/IADC-15-002