Why remote drug manufacturing evaluations won't really reduce FDA's backlog of inspections
For the first several months of the pandemic last spring, the FDA continued to plow through its user fee-enabled work on new drug and biologic applications, meeting nearly all of its goal dates.
But by last fall and into the winter, complete response letters and other delays began arriving in companies’ mailboxes as the agency struggled to catch up to a growing backlog of both domestic and foreign drug manufacturing inspections.
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