Partner David Rosen was quoted in a
Modern Healthcare article, "
Federal investigation finds holes in orphan drug approval process," about an investigation by federal regulators that found fault with the U.S. Food and Drug Administration's process for approving so-called orphan drugs.
While the report suggests there may be holes in the agency's documentation process, Rosen said, that doesn't mean that FDA reviewers aren't weighing the impact of a drug's regulatory or marketing history. "The fact that maybe all the i's aren't dotted or t's aren't crossed is a technical claim, but whether it has a true material bearing is another story," he said.