Remote Inspections: Stakeholders Seek Clarity As Some At US FDA Struggle With Process
Some lawmakers want FDA to prioritize in-person visits, but others are complaining that more remote inspections are needed because approvals are being delayed.
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Remote Assessments A Welcome Option For US FDA, But They’re Not Every Firm’s First Choice
“We're looking to expand the use of this tool make it a more routine part of our operations going forward,” says Michael Dutcher, deputy director, ORA Office of Human and Animal Food Operations. “In general, the response from industry has been pretty positive” about RRAs.
US FDA Likely To Embrace In-Person, Remote Combo For Facility Inspections Going Forward
System likely will evolve as post-pandemic world unfolds, but adds to list of agency programs expecting to continue using virtual platforms once in-person activities are no longer restricted by COVID-19.