FDA approves consent exception for experimental in vitro diagnostics

06/30/2011 | Clinica (subscription required)

The FDA has released a final rule that allows experimental in vitro diagnostics to be used in determining biological, chemical or nuclear agents without securing informed consent. To prevent abuse of the exception, investigators who use experimental in vitro diagnostics will have to submit documents to the agency in addition to their institutional review boards.

View Full Article in:

Clinica (subscription required)

Published in Brief:

SmartBrief Job Listings for Health Care

Job Title Company Location
Senior Director, Biostatistics
Edwards Lifesciences
Irvine, CA
Diagnostic Technician
Roche
Marlborough, MA
Test Technician
Roche
Marlborough, MA
Associate - Food and Drug
Keller and Heckman LLP
Washington, DC
Senior Paralegal - Research & Development, and Medical
Boehringer Ingelheim
Ridgefield, CT