What is the CPC?
A group of leading companies in the drug, device and biologics industries, the CPC works to improve the regulatory environment for combination products by developing and advocating policy positions on regulatory issues affecting combination products. The unique cross-industry membership of the CPC enables diverse thinking that leads to sound policies. This diversity distinguishes the CPC from other industry organizations.

• You'll be heard. With the CPC, you'll have a significant voice in decisions made and positions taken. Unlike large, traditional trade organizations, the CPC is a small but strong group of companies that works as a team.
• You'll learn a lot. Members meet regularly to share their experiences and thoughts on regulatory strategies involving combination products. The dynamic group discussions provide a learning forum that benefits even the most experienced professionals.
• You'll get things done. The CPC's active agenda and energetic membership ensures that things get done when they need to get done. Whether identifying and tackling issues of concern to members or responding to regulator's proposed regulations and policies, the CPC takes action.
• You'll be on the cutting edge. As a CPC member, you will be thrown in the thick of all the exciting issues and activities on the horizon. The January Summit on Issues Involving Combination Products, co-sponsored by RAPS and the CPC is just one example.

Resources and Correspondence

February 5, 2010 :: GMP Proposed Rule Comments FINAL :: pdf (83 KB)

January 29, 2010 :: Adverse Event Final Proposed Rule Comments :: pdf (83 KB)

August 7, 2009 :: Docket No. FDA-2009-N-0247; Food and Drug Administration Transparency Task Force; Notice of Public Meeting; Request for Comments :: pdf (115 KB)

July 23, 2009 :: Comments on Draft Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products; Docket No. FDA-2009-D-0179 :: pdf (152 KB)

June 11, 2009 :: Letter to Dr. Margaret Hamburg, FDA Commissioner :: pdf (47 KB)

June 8, 2009 :: White Paper: Increasing Focus on Combination Products :: pdf (406 KB)

May 22, 2009 :: Combination Products Coalition -- Wiki Project :: pdf (73 KB)

February 27, 2009 :: CPC: Draft Guidance for Industry and FDA Staff: FAQs on Pre-Clinical and Clinical Research on Combination Products :: pdf (20 KB)

June 30, 2008 :: Letter to European Commission re: Recast Medical Devices Directives, 6. Borderline Cases, Item 15. :: pdf (58 KB)

March/April 2008 :: An Uncertain Path, Medical Device Link :: pdf (511 KB)

January 22, 2008 :: CPC Open Door Forum Combination Products Guidance Survey and 2008 Policy Agenda. :: pdf (511 KB)

January 2, 2008 :: CPC Draft Guidance Comments :: pdf (60 KB)

January 2, 2008 :: Letter to Director Thinh X. Nguyen: Introduction to Combination Products Coalition. :: pdf (42 KB)

April 16, 2007 :: IN BIO Future: Past, Present, Future: FDA regulation of combination products and GMPs. :: pdf (301 KB)

March 5, 2007 :: Supplements and Other Changes to an Approved Application: Public Meeting (72 Fed. Reg. 574) :: pdf (323 KB)

January 22, 2007 :: Application of cGMP Regulations to Combination Products: Frequently Asked Questions, Proposed Guidance - 1/15/07 :: pdf (122 KB)

January 22, 2007 :: Appendix A - GMP Algorithm :: pdf (496 KB)

January 22, 2007 :: Appendix B - GMP Algorithm :: pdf (385 KB)

January 22, 2007 :: Appendix C - GMP Algorithm :: pdf (464 KB)

January 22, 2007 :: Appendix D - GMP Algorithm :: pdf (278 KB)

March 23, 2006 :: CPC Comments on FDA Adverse Event Concept Paper :: pdf (67 KB)

July 5, 2006 :: CPC Comments on Increasing Transparency in the Application of cGMP Regulations to Combination Products :: pdf (67 KB)

January 11, 2006 :: Docket No. 2005N-0098: Supplemental Comments FDA re: Cross-Labeling of Combination Products.

November 15, 2005 :: Regulatory Algorithm for Combination Product Cross Labeling Issue :: pdf (97kb)