The Food and Drug Administration (FDA) recently released guidelines for safety reporting for combination products that clarify which companies and products must abide by the final rules on post-marketing safety reporting (PMSR) requirements and how exactly to do so.
"In the past decade we have seen a marked increase in interest from manufacturers who seek to develop medical products that combine devices, drugs and/or biologics," FDA Principal Deputy Commissioner Amy Abernethy, M.D. said in a press release “While there are many variations of these combination products, some of the most innovative are being created to deliver the correct dose of a drug to a precise part of the body at set times. This can lead to more targeted treatments that ensure patients receive correct dosages without the need to remember to take their medicine at a precise time.
"But as this area has grown, so too has the need for information about the safety of these products when in routine use by patients," Abernethy continued in the press release. "Today, the FDA is taking another step to help applicants better comply with important product post-marketing safety reporting requirements and provide us timely, comprehensive safety information about combination products at established intervals. We are issuing guidance, finalized today, that will help applicants better understand how to submit their combination product post-marketing safety reports. This guidance reinforces FDA's expectations for timely post-marketing safety information about combination products."
The PMSR will let combination product developers know about submitting reports, record-keeping requirements and how to avoid duplications of safety information for their products. The additional constituent part-based PMSR requirements will not be enforced until July 2020.
For vaccine combination products, the requirements will not take effect until January 2021.