FDA background materials for a MDUFA 3 quarterly performance meeting covering the first quarter of FY 2017 say that the percentage of PMA originals an...
CDER director Janet Woodcock says that implementing informatics process management is the Centers highest priority in 2017.
FDA accepts for review three Merck and Pfizer NDAs for medicines containing ertugliflozin, an investigational SGLT2 inhibitor under development to hel...
FDA accepts for review a PTC Therapeutics NDA that was filed in protest for Translarna (ataluren) for treating nonsense mutation Duchenne muscular dys...
FDA lifts clinical holds against several Seattle Genetics Phase 1 trials of vadastuximab talirine (SGN-CD33A; 33A) in acute myeloid leukemia.
Consumer advocacy group Public Citizen urges Congress to reject three right to try bills (S 204, HR 878 and HR 1020) because they would put countless ...
Former FDA commissioner Mark McClellan says a speedier FDA review process is unlikely to benefit public health as much as improving product developmen...
Sen. Chuck Grassley (R-IA) expands his inquiry into potential misuses of FDAs orphan drug program in the wake of the agencys recent approval of Marath...