The CEO of the Biotechnology Industry Organization recently put forth some fresh thinking regarding the FDA and their role. Among other things, he proposes that FDA create a Chief Innovation Officer who would work more closely with external, non-government groups such as private industry and academia to stay on top of technological advances and keep the FDA informed of the latest science.
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ASTM E2500 Consensus Standard: An Overview of a New Approach to Validation
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Proven Steps to Reducing Waste in Process Validation
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