Thursday, February 1, 2018

Carter Alleges FDA Guidance Improperly Drives Compounding ...

Inside Health Policy-3 hours ago
FDA came under fire from Rep. Buddy Carter (R-GA) Tuesday (Jan. 30) for what he alleges is the agency's use of guidance documents as the basis for compounding enforcement actions. Carter's concerns were buoyed by a new policy from the Department of Justice which bars use of guidance to create binding standards, ...

Statement from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to mitigate impact of saline shortages during this flu season

As flu activity remains widespread across the U.S., the FDA continues to monitor this situation closely and in coordination with our colleagues at the U.S. Centers for Disease Control and Prevention. We’re continuing to take steps to help ensure that people with the flu have access to critical medical products, including antivirals, saline and other supportive care drugs and devices. Continue reading