FDA grants Cubist Pharmaceuticals fast track status for its late-stage antibiotic candidate ceftolozane/tazobactam (CXA-201) for treating various infections.
Endo says its original Opana is so similar to original OxyContin in use and abuse that FDA should determine that Opana was withdrawn for reasons of safety or effectiveness and cannot be referenced in an ANDA.
FDA issues a product safety alert for Covidien Endo GIA Articulating 60-3.5 Surgical Stapler Reloads after they were stolen from the manufacturer before being sterilized.
Federal Register Notice: FDA and the International Society of Pharmaceutical Engineering will co-sponsor a conference on a culture of quality in the pharmaceutical quality system.