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.
You may also be interested in...
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.
An FDA consultant and industry representatives recommend streamlining information requests during 351(k) application reviews and giving companies more than two days to respond; Eastern Research Group’s final assessment of the BsUFA II program finds positive views, but industry says more transparency is needed on timelines for delayed inspections.