Mar 21, 2018
EMERGO SUMMARY OF KEY POINTS:
The US Food and Drug Administration have pushed back enforcement of post-market safety reporting (PMSR) requirements for combination product manufacturers to give affected registrants more time to ensure compliance.
According to new FDA guidance, the delay affects portions of PMSR rules finalized in late 2016 in order to allow combination product applicants more time to implement appropriate reporting, recordkeeping and related technologies and systems.
FDA has set two new PMSR enforcement dates tied to which system combination product applicants use to submit individual case safety reports, or ICSRs:
Ahead of the new enforcement deadlines, FDA has issued additional draft guidance to more fully explain PMSR compliance requirements.
EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS: