More Guidance Forthcoming from FDA’s Office of Combination Products on CMC & GMP Expectations

FDA’s Office of Combination Products (OCP) will be sharing its growing knowledge base through new guidances and updates to its existing library that will help CP manufacturers better understand the regulatory expectations and navigate the shoals of marketing clearance.

With eight years of experience in coordinating the flow of applications and addressing the questions and unique challenges presented by the growing array of combination products entering the marketplace, OCP has targeted completing several guidance and regulation initiatives during 2011.

The new CP guidances will cover: ● chemical action ● classification, and ● post-approval submissions.  Updates are also being drafted of OCP’s: ● 2005 guidance on “How to Write a Request for Designation,” and ● 2006 guidance on “Considerations for Innovative Combination Products.”

Also expected to emerge from the agency’s pipeline this year are final regulations for combination product GMPs and for CP post-market safety reporting requirements.

OCP Deputy Director Patricia Love highlighted her office’s current initiatives at a “CMC Workshop” co-sponsored by the Drug Information Association (DIA) and the American Association of Pharmaceutical Scientists (AAPS) in Washington, D.C. in February.

Love addressed a session of the workshop focused on regulatory issues for combination products in the U.S., Europe and Japan.  She provided the participants with an overview of the current FDA CP regulatory process and offered advice on how firms should engage with it.  Her talk encompassed: ● definitions and assignments ● development and clinical trials ● the marketing application process ● GMPs and inspections ● post-approval changes, and ● OCP regulatory initiatives.  [Editor’s Note:  Love’s remarks are included in full below].

[The OCP Deputy Director’s insights are provided for subscribers here. See the IPQ “In the News” companion stories on combination product regulatory developments in Europe and Japan and on a proposal for a risk-based approach to regulator/industry interactions on CPs.  Nonsubscribers may purchase the full stories for $195 each by contacting Karen Bertani (