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- Title
Challenges Ahead for Companion Diagnostics.
- Authors
Schmidt, Charlie
- Abstract
The article reports on the approval given by the U.S. Food and Drug Administration (FDA) to vemurafenib, as well as the draft guidance issued concerning companion diagnostics. According to FDA officials, the guidance is needed to make sure that personalized drugs are provided only to possible responders. Both researchers and clinicians believe that the guidance will hamper innovation and restrict access to treatment. Information on the two companion diagnostics approved by the FDA is given.
- Subjects
UNITED States; DRUG approval; UNITED States. Food &; Drug Administration; ENZYME inhibitors; GUIDELINES; MEDICAL innovations; HEALTH services accessibility
- Publication
JNCI: Journal of the National Cancer Institute, 2012, Vol 104, Issue 1, p14
- ISSN
0027-8874
- Publication type
Article
- DOI
10.1093/jnci/djr535