The U.S. Department of Justice (DoJ) says a Federal Circuit ruling on so-called generic drug “skinny labels” threatens to undermine the Hatch-Waxman framework for bringing generics to market.
Human Drugs
Rare Disease Developers Welcome FDA Guidance
Rare disease drug developers and patient advocates are applauding a series of new guidance documents from FDA that bring long-awaited clarity to regulatory expectations and could help reduce risk in a high-stakes development landscape.
