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FDA publishes a draft guidance with an interim enforcement discretion policy for some Section 503 drug compounding using bulk drug...[ Price : $8.95]
FDA clears a Becton Dickinson 510(k) for what it describes as a novel blood collection device that gathers blood samples from a fi...[ Price : $8.95]
Sen. Elizabeth Warren and Rep. Jan Schakowsky reintroduce their bill to establish a generic drug manufacturing operation within HH...[ Price : $8.95]
FDA extends by three months its review of an Optinose supplemental NDA for Xhance (fluticasone propionate) as a treatment for chro...[ Price : $8.95]
FDA publishes an interim policy delaying regulatory action on drug compounding using bulk drug substances while the agency develop...[ Price : $8.95]
FDA grants one provision in a Provepharm petition asking for restrictions on the approval of ANDAs or NDAs citing ProvayBlue as th...[ Price : $8.95]
FDA approves Novartis Fabhalta to treat adults with paroxysmal nocturnal hemoglobinuria.[ Price : $8.95]
Rep. Andy Harris calls for an investigation to determine whether an FDA cozy relationship with the drug industry led to a 10-year ...