Rocky Mountain Regulatory Affairs Society - Comment

The Rocky Mountain Regulatory Affairs Society wishes to ask you to include our group's feedback to FDA regarding the proposed rule for Combination Products. See attached Case Study #5 write up, from the 12 January 2010 meeting "CGMPs for Combination Products–An Interactive Analysis with Industry and FDA" hosted by FDA, RAPS and the Coalition for Combination Products. The group participating via the internet from Denver would additionally like to add a comment regarding registration and related compliance issues, that are not specifically relevant to GMP’s, but are relevant to FDA’s development of rules applicable to combination products. As an “ambiguity” RMRAS notes confusion regarding the registration and listing requirements for CoatCo and PackCo and possibly StentCo (Case Study #5). We understand that CoatCo and PackCo are both contract manufacturers but -- The Guidance for Industry – Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (dated May 2009) lists in a footnote on page 6: Note # 17: Registration and listing requirements for drugs should also be met for combination products that include a drug as a constituent part, and for drugs intended as a constituent part of a combination product, regardless of which FDA center has the lead for review of the combination product.