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...
Federal Register Notice: FDA determines that GlaxoSmithKlines allergy drug Flonase (fluticasone propionate) nasal spray, 0.05 mg, was not withdrawn fr...
Federal Register Notice: FDA announces a 5/4 public meeting and an opportunity for public comment on Patient-Focused Drug Development for autism.
Federal Register Notice: FDA awards Biogen a priority review voucher for gaining approval of rare disease drug Spinraza (nusinersen), indicated for tr...
FDA Global Regulatory Operations and Policy deputy commissioner Howard Sklamberg leaves the agency to pursue new opportunities.
FDA Review posts Federal Register notices for the week ending 3/3/2017.
A new report says the 2.3% medical device tax in the Affordable Care Act, which was suspended for tax years 2016 and 2017, cost the U.S. economy 28,00...