Pandemic Perspectives: US FDA, NIH Tried To Be Flexible To Keep Rare Disease Trials Going
Both federal agencies extended grants to help investigators adapt to the changes mandated by the COVID-19 pandemic.
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US FDA proposed increasing staffing and resources for both programs during the next user fee program cycle, but industry representatives did not believe it necessary.
More patient-centric trial designs also may be coming due to pandemic-related advances, Marks says.
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.