Manufacturing (1 - 2 of 2 items) in Past Year
Drug Safety: FDA Has Improved Its Foreign Drug Inspection Program, but Needs to Assess the Effectiveness and Staffing of Its Foreign Offices
GAO-17-143: Published: Dec 16, 2016. Publicly Released: Jan 17, 2017.
The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), has increased its foreign drug inspections and enhanced its ability to prioritize drug establishments for inspection. The number of foreign inspections has consistently increased each year since fiscal year 2009. Beginning in fiscal year 2015, FDA conducted more foreign than domestic inspect...
Drug Shortages: Certain Factors Are Strongly Associated with This Persistent Public Health Challenge
GAO-16-595: Published: Jul 7, 2016. Publicly Released: Jul 7, 2016.
When available supplies of prescription drugs are insufficient, patient care may be adversely affected. The number of new shortages has generally decreased since 2011, while the number of ongoing shortages remained high.Number of Drug Shortages from January 2010 through December 2015 To help address shortages, the Food and Drug Administration (FDA) prioritized the review of—more quickly reviewed...