FDAnews has teamed Chris Sloan, Quintiles Consulting, and Michael Morton, Medtronic, in a 90-minute presentation on the FDA advisory panel process. You’ll discover tips and guidance that are the fruit of a combined five decades of device regulatory experience.
Impax Laboratories can market generic versions of Genzyme’s kidney disease drugs Renvela and Renagel in 2014 under a settlement with the brand drugmaker. Genzyme has granted Impax a license to sell a generic version of Renvela (sevelamer carbonate) 800-mg tablets beginning March 16, 2014, Impax said Tuesday. Impax can also sell oral suspension versions of Renvela and Renagel (sevelamer hydrochloride) beginning Sept. 16, 2014. Drug Industry Daily