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FDA drug approvals slipped in 2010
January 2011

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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