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Regulatory Focus™ > News Articles > FDA Details Combination Product Postmarket Safety Reporting Requirements

FDA Details Combination Product Postmarket Safety Reporting Requirements

Posted 09 February 2017 | By Michael Mezher 

FDA Details Combination Product Postmarket Safety Reporting Requirements

The US Food and Drug Administration (FDA) is looking to clarify its expectations for combination product manufacturers adjusting to the agency's recently released final rule for postmarket safety reporting.

In a webcast last week, John Weiner, associate director for policy at the Office of Combination Products (OCP), explained which parts of the rule manufacturers should be following now, and which will they will be required to comply with beginning July 2017.

Weiner also said the agency is working to develop guidance on the rule before the remaining provisions come into effect.

"The agency is developing draft guidance right now, and welcomes comments and questions in the interim," Weiner said.

Final Rule

According to Weiner, FDA's goal in developing the final rule was to establish consistent, streamlined requirements for postmarket safety reporting.

In general, the rule requires manufacturers marketing combination products to comply with the postmarket safety reporting requirements for the application type for their product (i.e. new drug application (NDA), abbreviated new drug application (ANDA), biologic license application (BLA), 510(k) or premarket approval (PMA)), as well as the reporting requirements for any constituent parts for their product.

Figure 1. PMSR Requirements Applicable to Both Combination Product and Constituent Part Applicants

PMSR - Fig 1

However, for now, Weiner says FDA only expects manufacturers to comply with postmarket safety reporting requirements for the application type for their product. Beginning in July 2017, combination product applicants will need to comply with reporting requirements for the constituent parts of their product as well.

"At this point, in order to help everyone roll this out smoothly, we're recommending that you just address the first set of requirements until you get further information from us on what to do, if anything, between now and the compliance date," Weiner said.

Figure 2. Additional PMSR Requirements for Combination Product Applicants

PMSR - Fig 2

Additionally, starting July 2017, constituent part applicants will be required to share safety reports with each other for applications for the same combination product.

While the final rule directs manufacturers to follow the specific regulations for postmarket safety reporting, Weiner says that some requirements will be different for combination product sponsors in an effort to streamline requirements across product types.

For example, Weiner said, "If you are marketing your combination under a device application and it includes a drug, then the 15-day report requirements do apply, but the deadline is different. We've made the deadline for those reports 30 calendar days rather than 15 days to enable those reports to be satisfied in keeping with the timeframes for device reporting, just to make that system more efficient and easier to satisfy."

Record Retention

In order to simplify recordkeeping requirements, Weiner says the agency decided to require combination product applicants to retain PMSR records "for the longest retention period applicable to any report type for the product," which will typically be 10 years.

"In most cases, the longest retention period that would apply would be the period that applies for 15-day reports, which is 10 years," Weiner said.

On the other hand, constituent part applicants will be held to the record retention requirements for each specific report type, but would be required to retain information sharing records for the longest retention period for any reporting requirement applicable to their product.


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