FDA is pleased to report that the majority of the PMRs/PMCs in the FY2017 report were successfully completed (fulfilled) or are progressing toward completion according to the original schedule; very few PMRs/PMCs are considered ‘delayed.’ Additionally, the
FY2017 Report to Congress on the Backlog of PMRs/PMCs shows that progress continues to be made in closing out PMRs/PMCs in the "backlog.”
The FDA is committed to ensuring that postmarketing requirements (PMRs) and postmarketing commitments (PMCs), which further describe the safety, efficacy, and/or optimal use of a drug, are conducted and reported as required.
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