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.
FDA approves a Synergy Spine Solutions PMA for its Synergy Disc, a motion-preserving artificial cervical disc.
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.
FDA approves a Synergy Spine Solutions PMA for its Synergy Disc, a motion-preserving artificial cervical disc.
A leading myeloma researcher says FDA’s draft guidance endorsing minimal residual disease as a potential basis for accelerated drug approvals in multiple myeloma marks a watershed moment for the field.
The U.S. Senate Special Committee on Aging raises concerns about FDA’s handling of foreign drug manufacturing violations and how those decisions could affect military readiness and national security.
