RAPS, Combination Products Coalition to Address FDA's Final Rule in Workshop

The Regulatory Affairs Professionals Society (RAPS) is working with the Combination Products Coalition (CPC) to offer a workshop on FDA’s final rule on current Good Manufacturing Practices (CGMPs) for combination products. 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.

Representatives from FDA’s Office of Combination Products along with industry experts will discuss the contents of the final rule and compare it with the proposed rule. The rule’s likely impact on industry will be examined. According to FDA in its Federal Register posting on the final rule, the rule “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.”

An interactive session will feature CBER, CDER, CDRH panel discussion, allowing attendees to provide feedback directly to FDA.

Registration for this workshop is currently open. Interested members of the media should contact RAPS Senior Manager of Communications Zachary Brousseau at zbrousseau@raps.org or +1 301 770 2920, ext. 245.

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