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Drug advertising consultant Bob Ehrlich says the recent wave of FDA enforcement letters on drug promotion activities is reshaping ...[ Price : $8.95]
As part of FDAs recent implementation of the Quality Management System Regulation, a new risk-based inspection model is set to cha...[ Price : $8.95]
PTC Therapeutics withdraws its NDA resubmission for Translarna (ataluren) to treat nonsense mutation Duchenne muscular dystrophy, ...[ Price : $8.95]
Sen. Tom Cotton (R-AR) urges FDA to investigate whether illegal or unregulated Chinese-sourced active pharmaceutical ingredients h...[ Price : $8.95]
FDA issues Disc Medicine a complete response letter for its experimental therapy bitopertin, indicated for treating erythropoietic...[ Price : $8.95]
FDA cites Zydus Lifesciences sterile drug manufacturing facility in Vadodara, India, for significant quality control and aseptic p...[ Price : $8.95]
Singer further suggests that Congress could explore forms of international drug reciprocity, allowing Americans to purchase certai...[ Price : $8.95]
A law firm examines FDAs renewed scrutiny of direct-to-consumer television advertising after issuing seven untitled letters so far...