Tag Archives: Sequester

FDA Check-Up: Drug Development and Manufacturing Challenges

Paul Hastings

I have over 27 years of experience in the biotechnology and pharmaceutical industry. My current company, OncoMed Pharmaceuticals, is working at the cutting edge of oncology research, focused on antibodies that target a specific set of cells within tumors, known as tumor initiating cells, that drive the growth of the tumor and can differentiate into various cell types within the tumor. Currently, we have five products in clinical development in over 13 completed or ongoing Read More >

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Sequester Threatens FDA Mission

FDA115x76

One aspect of sequestration isn’t doing anything to reduce the deficit, but could be delaying patient access to new drugs and medical devices, according to the FDA’s Janet Woodcock at a House subcommittee hearing on Friday. The FDA is being denied access to some of the user fees paid by the drug and device industries, which are intended to fund FDA’s review and oversight programs and ensure timely patient access to new and effective treatments. Read More >

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