USA – FDA Again Pushes Back Compliance Date for Safety Reporting Requirements for Combo Products

A little more than a year after pushing back the date by which combination product companies must comply with certain postmarket safety reporting (PMSR) requirements, the US Food and Drug Administration (FDA) on Tuesday extended the compliance deadline again.

The updated guidance explains how FDA does not intend to enforce 21 CFR 4.102(c) and (d) (constituent part-based PMSR requirements), 4.104(b)(1) and (b)(2) (submission process for constituent part-based Individual Case Safety Reports (ICSRs)), and 4.105(b) (recordkeeping requirements) until:

  • 31 July 2020 for combination product applicants using the FDA Adverse Event Reporting System (FAERS) and Electronic Medical Device Reporting System (eMDR) to report ICSRs.
  • 31 January 2021 for combination product applicants using the Vaccine Adverse Event Reporting System (VAERS) to report ICSRs.

Both dates were pushed back by a year when compared with the previous version of the guidance from March 2018…