Fresh From the Biotech Pipeline — 2011

FDA pharma/biotech partner David Fox recently spoke with academic trade journal Nature Biotechnology regarding landmark drug approvals in 2011, FDA policy changes, and the outlook for generic biologics. The resulting article, “Fresh from the biotech pipeline – 2011,” features several quotes from David on FDA approvals in the area of personalized medicine and companion diagnostics. David emphasizes the importance of the approval of Zelboraf, a drug manufactured by Genentech. He confirms in the article, “[Zelboraf was an] important decision because of what it signaled in terms of personalized medicine, with the diagnostic built into the drug approval. It requires the agency to have two of its centers [the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health] working together closely towards the approval of a product.”

To read the article, please click the above link.

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