FDA announces new compliance deadlines for the combination product post-market safety reporting (PMSR).
In order to allow combination product applicants more time to get their procedures and reporting in order the FDA have pushed the PMSR compliance deadlines to 2019 and 2020.
The PMSR rules were finalised in 2016 but the FDA have chosen to push this to July 2019 for combination products using the FAERS & eMDR reporting systems. In addition by Jan 2020 for combination applicants using the VAERS reporting system.
The FDA’s DRAFT guidance for this can be found here.
For regulatory management and tracking of your combination products or advice from our team reach out to Instem via +44 1785 825653 or email [email protected].