Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for QED Therapeutics Truseltiq (infigratinib)....
ProPublica and the Pittsburgh Post-Gazette take aim at alleged FDA failures to properly manage a timely response to reports of problems with Philips R...
FDA publishes a draft guidance with an interim enforcement discretion policy for some Section 503 drug compounding using bulk drug substances.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...
