A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
The FDA’s Anti-Infective Drugs Advisory Committee Friday recommended approval of GlaxoSmithKline’s (GSK) 40-mg/kg raxibacumab IV solution, with or without an antimicrobial, to treat adults infected in an airborne anthrax attack. The committee voted 16 to 1 in favor of the drug, with one abstention. All panelists agreed GSK’s animal studies had shown efficacy but one member was concerned the drug’s effect was not proven statistically significant. Drug Industry Daily