FDA Manufacturing-Change Reviews Will Shift From Compliance Office To ODE
This article was originally published in The Gray Sheet
The move is in line with the agency’s intention to focus on the total product life-cycle, such that the same staffers that review an original marketing submission will look at the safety and effectiveness of manufacturing changes.
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The division officially began taking over reviews of 30-day manufacturing notices from the Office of Compliance Feb. 1 as part of a larger reorganization.
A restructuring in the Office of Device Evaluation, incorporating dozens of new hires, is intended to reduce the number of reviewers reporting to each manager. It took effect last week.