FDA’s New Inspections Council Whipping Up Policy Around Remote Regulatory Assessments
Also: Agency carries out more domestic surveillance inspections in FY ’21 than anticipated
The US FDA says in a report that its Inspectional Affairs Council will develop Remote Regulatory Assessment policies for all commodities the agency oversees. RRAs were launched by the FDA as a way to check on a firm’s regulatory compliance without sending an investigator on-site.
You may also be interested in...
COVID-19 pandemic’s latest variant has pushed FDA to pump brakes again on performing on-site surveillance inspections through at least 19 January. Meanwhile, associate commissioner says Remote Regulatory Assessments “are here to stay.”
The COVID-19 pandemic’s latest variant has pushed the US FDA to pump the brake once again on performing on-site surveillance inspections through at least 19 January. Meanwhile, an agency official says Remote Regulatory Assessments “are here to stay.”
The pandemic caused the US FDA’s Office of Regulatory Affairs to consider ways it can be more nimble in its inspectional activities, including launching an agency-wide council to tackle and solve inspection-related issues, the ORA’s Elizabeth Miller says.