The FDA has issued a final guidance titled “Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff” that specifies how to comply with postmarketing safety reporting (PMSR) requirements for combination products issued in 2016. The guidance cites several examples of combination product applicants subject to the rule, including “A company that holds an approved NDA for a pre-metered dry powder inhaler copackaged with a filled drug product cartridge (a co-packaged combination product).”
As an example of a situation that would require filing of a five-day report, the guidance describes a scenario in which: “The applicant for a prefilled rescue inhaler approved under an NDA determines that a reportable adverse event was caused by a design flaw that causes the inhaler actuator to fail and the drug to not be delivered. The design flaw is known to be present in the product in the field, and the product in the field can fail in the same manner, likely resulting in life-threatening injury or death (which would pose an unreasonable risk of substantial harm to the public health). “
The guidance also suggests scenarios where combination product applicants for inhalers do or do not need to submit malfunction reports.
FDA Principal Deputy Commissioner Amy Abernethy commented, “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. 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. Today, the FDA is taking another step to help applicants better comply with important product postmarketing 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 postmarketing safety reports. This guidance reinforces FDA’s expectations for timely postmarketing safety information about combination products.”
Read the FDA announcement.
Read the FDA guidance.
