Pharma Import Alert: FDA Working Towards Consistency, Better Decision Making
This article was originally published in PharmAsia News
FDA’s broad reorganization may not create the same super-specialization for the import staff that is coming to other parts of the agency, but a process overhaul appears on its way regardless.
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Agency planned for up to 100 participants in program allowing expedited entry of some imports, but only approved 13.
Agency’s Program Alignment Group recommends “commodity-based and vertically-integrated programs” to improve efficiency and communication.
An initial look at data from the first year of the import screening system’s full operation finds PREDICT is effective in directing FDA inspectors to high-risk products, Deputy Associate Commissioner for Regulatory Affairs Steve Solomon says.