"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
Senior Director Medical Affairs
Edwards Lifesciences
Irvine, CA
Senior Scientist - Cell Engineering Group
Pfizer
San Francisco, CA
Area Reimbursement Manager (CT, MA, MD, ME, NH, NJ, NY, PA, VT)
SI-BONE, INC
Multiple Locations, SL_Multiple Locations
Medical Director - Physician
Willamette Valley Community Health
Salem, OR
Medical Director - Physician
Willamette Valley Community Health
Salem, OR