Issue Date: June 29, 2015
Companion Diagnostics And Drugs Follow New Regulatory Path
Last summer, the Food & Drug Administration published its final guidance on the development and approval path for companion diagnostics. These in vitro tests and devices put personalized medicine into practice by providing, FDA says, the “information essential for the safe and effective use of a corresponding drug.” In clinical trials and medical care, the diagnostics will help identify patients most likely to benefit from a particular therapy.
FDA approved . . .
To view the rest of this content, please log in with your ACS ID.
- Chemical & Engineering News
- ISSN 0009-2347
- Copyright © American Chemical Society