FDA publishes a draft guidance with an interim enforcement discretion policy for some Section 503 drug compounding using bulk drug substances.
FDA clears a Becton Dickinson 510(k) for what it describes as a novel blood collection device that gathers blood samples from a fingerstick that produ...
Sen. Elizabeth Warren and Rep. Jan Schakowsky reintroduce their bill to establish a generic drug manufacturing operation within HHS.
FDA extends by three months its review of an Optinose supplemental NDA for Xhance (fluticasone propionate) as a treatment for chronic rhinosinusitis.
FDA publishes an interim policy delaying regulatory action on drug compounding using bulk drug substances while the agency develops a required list of...
FDA grants one provision in a Provepharm petition asking for restrictions on the approval of ANDAs or NDAs citing ProvayBlue as the reference-listed d...
FDA approves Novartis Fabhalta to treat adults with paroxysmal nocturnal hemoglobinuria.
Rep. Andy Harris calls for an investigation to determine whether an FDA cozy relationship with the drug industry led to a 10-year delay in acting agai...
