US FDA’s Remote Evaluations Of Drug Manufacturing Facilities May Become Public
Executive Summary
Agency is considering posting its observations from remote assessments of facilities, assistant commissioner Miller tells annual FDLI meeting; new FDA Inspectional Activities Council will develop an action plan for the agency’s inspections program.
You may also be interested in...
Forty-Eight US FDA Drug Application Decisions Delayed By Pandemic's Deferred Inspections
US FDA 'resilience' report charts how inspection backlog grew and impacted approvals and compliance follow-up.
US FDA Explains Why Remote Interactive Evaluations Guidance Took So Long
Time taken for interagency alignment, lessons learned from foreign counterparts will increase use of remote video tours, say FDA officials..
Remote Site Visits Will Help US FDA Keep Reviews On Track During Remainder Of Pandemic
Video facility tours expected to help clear way for timely drug and biologic approvals while COVID-19 still prevents inspections.