1. Pink Sheet

For COVID-Impacted Studies, US FDA Loosens Video Conferencing But Tightens Home Infusion Guidance

 
• By Sue Sutter

Also, use of alternative labs or imaging centers depends upon type of assessment and reason it is being performed, FDA's revised guidance states; missed milestones for postmarketing studies required under accelerated approval will need to be justified.

Doctor radiologist looking at x-ray images
Alternative sites may be used for routine procedures, such as chest x-rays, to ensure study participant safety. • Source: Shutterstock

Sponsors’ ability to use alternative laboratory or imaging centers for protocol assessments in clinical trials impacted by COVID-19 will depend upon the type of assessment and the reason it is being performed, the US Food and Drug Administration said.

The agency’s latest guidance

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