The US must bolster study on how to best craft regulations that bring drugs, medical devices and vaccines to market, the commissioner of the US Food and Drug Administration stressed in a speech delivered yesterday (September 16th) in Philadelphia. linkurl:Margaret Hamburg,;http://www.fda.gov/AboutFDA/CommissionersPage/default.htm the former New York City health commissioner who was named FDA commissioner earlier this year, was speaking at the annual Regulatory Affairs Professional Society conference to approximately 850 representatives from pharmaceutical companies, biotechs, and medical device manufacturers.
"Just as biomedical research has evolved in the past decades, regulatory science -- the science and tools we use to assess and evaluate product safety, efficacy, potency, quality and performance -- must also evolve," she said. Hamburg added that too little attention and resources are paid to regulatory science as a discipline that can help the FDA protect and benefit American citizens. "Our efforts...
RAPS 2009 Conference
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