July 15th, 2011
Posted by Caroline Popper, M.D., M.P.H.
This week, the FDA issued draft guidance for in vitro companion diagnostics. After a day or so of reflecting about it, here’s what I think it may mean for you:
Overall, while the guidance itself may not be BIG news, it does seem to make good sense for business and to offer life science companies some flexibility. Whether you are a therapeutics company or a diagnostics company, you should see new opportunities as a result.
Following are the key points I took away from my review of the guidance:
- The FDA acknowledges that not all co-development of diagnostic tests and therapeutic drugs can occur simultaneously. Thus, there is room for you to secure approval of a drug before the test is available and also to seek to modify the drug’s label as new diagnostics information emerges. There is also room for you to potentially market an as yet uncleared or unapproved test, if the marketing of the test is critical in the context of a drug. Read the rest of this entry »