The Council on Pharmaceutical Quality will oversee implementation of the initiative, which covers aseptic processing, quality systems, computerized systems in clinical trials, process analytical technologies and combination products.

FDA’s draft guidance on systemic lupus erythematosus drug development lists four possible claims that the agency “may be willing to approve”: reduction in disease activity; organ-specific lupus treatment; complete clinical response/remission; and reduction in flares.

FDA is planning to develop a Risk Minimization Action Plan website, an agency risk management guidance states