FDA Housekeeping: Preemption Sweep From Regs
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency says it cannot justify preemption stance in the physician labeling rule in the wake of the 2009 Wyeth v. Levine Supreme Court decision.
You may also be interested in...
Pharma Outside the Fray As Obama Re-Evaluates Bush’s Pre-emption Policy
The good news for drug firms about President Obama's memo curtailing federal pre-emption state laws: it won't have any real impact on industry. The bad news: it won't matter because pre-emption in the Rx arena was already dealt a body blow in the Supreme Court's recent ruling in Wyeth v. Levine
Pre-emption After Supreme Court Ruling May Depend On How FDA Weighs Risk
While the Supreme Court's landmark ruling in Wyeth v. Levine dashes pharmaceutical industry hopes for broad protection from product liability lawsuits, it will not trigger any sea change in litigation. Instead, the opinion seems likely to maintain the status quo and restrict the situations in which companies can claim they provided adequate warning of a drug's risks
Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.