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Posted 19 December 2016 | By Zachary Brennan
More than the seven years after it was first proposed, the US Food and Drug Administration (FDA) on Monday finalized new postmarket safety reporting requirements for combination products.
The final rule, first proposed in 2009, which is the first time the agency has issued specific recommendations for combo products, is part of FDA’s efforts to ensure more consistent postmarketing safety reporting for these drug/device, biologic/device, biologic/drug or drug/biologic/device products, while enabling companies to be as efficient as possible with their reporting.
“These regulations for drugs, devices, and biological products share many similarities; however, each set of regulations has certain unique reporting requirements, standards, and timeframes based in part on the characteristics of the type of product,” FDA said in explaining the need for the final regulations. “These variations among the regulations and lack of clarity on how to apply these requirements to combination products can result in inconsistent and incomplete postmarketing safety reporting for combination products and their constituent parts.”
The final rule comes as FDA in August said it is beginning a new pilot project linked to its intercenter consult request (ICCR) process for combination products of drugs, medical devices and/or biologics.
The agency said it received 16 sets of comments on the proposed rule, with commenters seeking clarification of the scope of the proposed rule, among other issues.
"After considering the comments received on the proposed rule, the Agency has made clarifications and other revisions in the final rule to, among other things: (1) Clarify that the final rule applies only to combination product and constituent part applicants; (2) clarify when a single report may suffice to comply with more than one reporting requirement; and (3) incorporate biological product deviation reporting and device correction and removal reporting requirements applicable to combination product applicants," FDA said.
In addition to the application type-based reporting requirements (depending on if parts of the combo product were approved under a new drug application (NDA) or biologics license application (BLA), etc.), the final rule requires combination product applicants to submit additional reports based on the constituent parts included in the combination product (e.g., malfunction reports if the combination product includes a device, field alert reports if it includes a drug and biological product deviation reports if it includes a biologic).
The 83-page final rule also requires constituent part applicants (those who have approved parts of the combo product) to share certain postmarketing safety information they receive with one another. And it specifies how combination product and constituent part applicants must submit postmarketing safety reporting data to FDA and what records they must maintain.
In terms of changes between the proposed and final rule, FDA has:
Furthermore, in terms of efficiency for sponsors, FDA notes that “if the applicant has submitted one type of report and that report: includes all of the information that would also be required in another type of report; is required to be submitted in the same manner under this rule as that other report; and is submitted within applicable deadlines, the submission of the single report will be considered to satisfy both reporting obligations.”
Final Rule: Postmarketing Safety Reporting for Combination Products
Tags: combo product rule, FDA postmarket regulations, postmarket safety of combination products
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