"Design defect" suit threatens FDA review process

03/17/2013 | Politico (Washington, D.C.)

The "design defect" theory behind a lawsuit against generic-drug-maker Mutual Pharmaceutical could result in a wave of lawsuits second-guessing the approval of any drug, former FDA Deputy Commissioner Dr. Scott Gottlieb writes. "The theory would allow state juries to relitigate the risk-benefit analysis that is at the very core of the FDA's authority to approve prescription drugs," he writes.

View Full Article in:

Politico (Washington, D.C.)

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
Associate Director, Compliance Business Partner I
Boehringer Ingelheim
Ridgefield, CT
Attorney
U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Office of the Chief Counsel
Silver Spring, MD, MD
Counsel – Regulatory Affairs
RAI Services Company
Winston Salem, NC
Senior Manager, Clinical Affairs - Advanced Technology
Edwards Lifesciences
Irvine, CA
Director, Litigation & Investigations EMEA
Gilead Sciences
Stockely Park