Response—FDA Regulations for Drug Development

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Science  02 Jul 2010:
Vol. 329, Issue 5987, pp. 33
DOI: 10.1126/science.329.5987.33-c

I thank Behrman and Woodcock for their Letter. Woodcock acknowledged the ongoing confusion in her Brookings' presentation of 14 September 2009 (1), in which she stated that the combination rule is widely misinterpreted, to the extent that the FDA would be developing guidance on the topic. Further clarification of the combination rule as it pertains to non-fixed drug combinations is urgently needed to support innovative drug development. Genentech is encouraged by the FDA's 8 June 2010 Federal Register request for comment on the co-development of investigational drugs (2)—an important step in the development of guidance. The Behrman and Woodcock Letter highlights the importance of decreasing real and/or perceived barriers to bringing novel combination therapies to patients with serious and unmet medical conditions.


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