Rosen Discusses New FDA Guidance on Generics

Partner David Rosen is quoted in a Cuidados de saúde modernos article, “FDA to pave clearer path for generic drugs,” about new agency guidance that aims to make it easier for generic pharmaceutical developers to plan how they can copy complex drugs.

While the new guidance provides some flexibility in evaluating drugs that face roadblocks to market, Rosen said, there is some gray area in defining how much generics can vary. “How much generic drugs can vary and not affect the clinical effect or safety profile remains to be seen,” he said. “We have to make sure we do things that are in the best interest of the patients.”