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September 18-19, 2014

September 18, 2014

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FDA drug approvals slipped in 2010
January 2011
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WASHINGTON—The U.S. Food and Drug Administration (FDA) approved about 21 drugs in 2010, down from 25 in 2009 and 24 in 2008, but higher from a recent low of 18 in 2007. Most analysts believe the drop reflects a tougher environment at the FDA, with regulators stepping up their scrutiny of safety issues in drugs for many key disease areas. Although the 2010 figures are a bit lower than previous years, FDA spokeswoman Sandy Walsh told The Wall Street Journal that there's "no systemic change in how the FDA is approaching drug approvals." The FDA approved a few potential blockbusters, but some of the most highly anticipated new products were delayed until this year or beyond.

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