FDA Final Rule on Manufacturing of Combo Products Likely to Answer Some Questions, Raise Others

Posted 25 February 2013 | By Zachary Brousseau 

The US Food and Drug Administration (FDA) recently released its final rule on current Good Manufacturing Practices (CGMPs) for combination products. In its Federal Register notice on the final rule, FDA wrote that it "sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for 'single-entity' and 'co-packaged' combination products."

According to Tom Hutchinson, vice president of regulatory affairs with Davol Inc., the rule is likely to clarify certain questions for some manufacturers and marketers of combination products, and raise questions for others.

Hutchinson is among the presenters who will participate in a workshop hosted by RAPS and the Combination Products Coalition (CPC) that will examine the rule and FDA's plan for implementation. The workshop, CGMPs for Combination Products-Final Rule and Implementation: An Interactive Analysis With Industry and FDA, will take place 28 February, 11:00 am-4:00 pm EST, at the RAPS training center in Rockville, MD, USA, and also will be available online as a live webcast.

"The importance of the publication of the final rule in the FederalRegister is that it now provides a framework for discussions with FDA," said Hutchinson. "Prior to this release, the agency was precluded from speaking very much about its thinking or interpretation. There are some questions that have been answered within the preamble to the final rule, such as when the tamper-evident closure requirements would apply, or that yield calculations would not apply to the device component of a drug/device combination product."

During the RAPS/CPC workshop, representatives from FDA's Office of Combination Products and industry experts will discuss the contents of the final rule and how it differs from the proposed rule, as well the rule's likely impact on industry and how to comply. Attendees will then work in small groups facilitated by experts from CPC, using case studies to apply the final rule, analyze ambiguities and identify approaches for effective implementation.

Experts from FDA's Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research and Center for Devices and Radiological Health also will participate in an interactive panel discussion on implementation of the final rule. Attendees will be able to provide feedback and ask questions on additional topics not addressed during the case study exercise.

Following the program, RAPS and CPC will summarize major themes that emerge from the workshop and submit comments to FDA that agency officials will consider when developing guidelines for implementation.

"Attendees at the workshop will be able to really focus on the questions of how the regulation should be implemented, now that the 'what' has been documented. They will have an opportunity to discuss their interpretation of the implementation of the final rule with other deeply interested professionals as they review the case studies, and potentially to influence the agency as any guidance documents are developed and issued," said Hutchinson.

Registration for this workshop is open.

Tags: cGMP

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