February 5, 2013

CGMPs for Combination Products–Final Rule and Implementation: An Interactive Analysis with Industry and FDA

In the wake of the U.S. Food and Drug Administration (FDA) issuing the final rule on current Good Manufacturing Practices (CGMPs) for combination products, the Combination Products Coalition (CPC), in collaboration with the Regulatory Affairs Professionals Society (RAPS), will be hosting an interactive session examining the contents of the final rule and the agency’s implementation plan.

During the program, happening on Thursday, February 28th at the RAPS Training Center in Rockville, MD, attendees will hear directly from experts at each of the FDA centers and industry regarding what the final rule includes, with an emphasis on deviations from the proposed rule. In-person attendees will work with industry peers in case study breakout sessions, where they will have the opportunity to apply the final rule, analyze the rule’s remaining ambiguities and identify approaches for effective implementation. During the final recap session, the expert facilitators will present and connect major themes identified during the breakouts, and all attendees will have the opportunity to provide feedback directly to the experts at the various centers responsible for developing the implementation guidance regarding any other ambiguities not addressed in the case studies.

CPC and RAPS will collaborate to compile the major themes that emerge from the program regarding implementation and submit them to FDA for consider in developing its implementation guidance.

The program is intended for manufacturers (including contract manufacturers), combination product developers, consultants and legal counsel who are involved in regulatory, quality and compliance at all professional levels and can be attended in person or via webcast. For more information and to register, please visit the RAPS event page. As capacity for this event is limited, early registration is encouraged!

January 23, 2013

Combination Products Coalition pleased with FDA publishings

The Combination Products Coalition is pleased to see the FDA guidance published on when submissions would be required for postapproval modifications to a combination product. Although we will continue to review individually and as a coalition our initial assessment is that it would increase the number of filings pretty radically by declaring that low risk device constituent parts are all of a sudden to be viewed through the PMA lens.

This is quick reaction, and we will be studying the document in more depth and filing comments. We appreciate FDA’s efforts to bring some clarity to this very murky area, and we truly appreciate the complexity of the task, but we are concerned that the current draft made needlessly and significantly increase the number of postmarket submissions combination product companies need to file.

January 22, 2013

FDA released the final rule on current good manufacturing practices for combination products

The U.S. Food and Drug Administration (FDA) released the final rule on current good manufacturing practices (cGMPs) for combination products on Friday, January 18, 2013. This rule is intended to clarify how the agency’s GMP requirements should be applied to the manufacturing operations of combination product companies. On the positive side, the rule seeks to streamline the requirements to minimize needless duplication between drug, medical device and biological product requirements.

Overall, there was very little changed from the proposed rule to the final rule. It is the hope of many within the industry that now that the final rule has been published, FDA will begin to communicate more freely with industry stakeholders, as many feel that clarification is still needed on how GMPs are applied to combination products.

Manufacturers will now have 180 days to sort all of the elements of the rule out before it becomes effective. While this should not, in theory, cause any issues because the rule did not change existing law, this process will hopefully also clarify how the GMPs get applied to combination products more fundamentally, and many companies may not have understood what FDA would say they intended the rules to be previously.

As such, it is going to be terribly important that FDA come out with the implementing guidance very quickly so that companies can start modifying their quality systems as necessary.

As part of the FDA communication strategy, a stakeholder webinar is being held to highlight the innovation and transparency value of this rule, noting that industry has been asking FDA to finalize it. The stakeholder webinar will be held Thursday, January 24, 2013 from 2:30 p.m. – 3:15 p.m., ET, and will consist of a brief presentation by John Weiner, Associate Director for Policy, Office of Combination Products.

The webcast may viewed at

Learn more about participating in the stakeholder webinar.

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