US FDA Freezes Inspections And Outside Meetings. Will Review Goal Dates Stay Put?
Sponsors have been asked to switch to teleconferences with FDA staff as the agency prepares for more of its employees to work from home.
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If agency has concerns about facilities it cannot inspect, it will generally issue complete responses, Q&A guidance says.
Officials explain how remote record reviews, site transfers and other factors can green-light approvals of drugs and biologics.