Rosen Quoted on Generic Drug Guidelines

27 October 2011 Bloomberg News News
Foley Partner David Rosen was quoted in an article that appeared in Bloomberg News on October 27, 2011 titled "FDA tightens standards to prove generics can be swapped." Rosen discusses in-progress FDA guidelines that will impose tighter standards for generic drug makers. He states that the guidelines will potentially require companies conducting generic equivalence studies to recruit nearly twice as many people for testing, adding that a new equivalency study would require several months to test generic products against the original versions.

Related Services