Drug user fee negotiators confront lingering divisions over FDA’s “America First” proposals and the structure of hiring commitments, according to just-posted meeting minutes.
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.
Drug user fee negotiators confront lingering divisions over FDA’s “America First” proposals and the structure of hiring commitments, according to just-posted meeting minutes.
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.
A leading myeloma researcher says FDA’s draft guidance endorsing minimal residual disease as a potential basis for accelerated drug approvals in multiple myeloma marks a watershed moment for the field.
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.
