FDA recently released two eagerly-anticipated proposed rules that impact how combination products are regulated.

A Proposed Rule on Current Good Manufacturing Practice Requirements for Combination Products was published in the Federal Register on September 23, 2009 (available at: http://edocket.access.gpo.gov/2009/pdf/E9-22850.pdf).

Then, on October 1, FDA published a Proposed Rule on Postmarket Safety Reporting for Combination Products (available at: http://edocket.access.gpo.gov/2009/pdf/E9-23519.pdf).

Both rules follow the same basic concept, in that a combination product manufacturer will follow a single set of rules attached to a drug, device, or biological product consistent part, but will then graft on portions of other sets of rules.

The publication of these new rules will enable important dialogue among the agency, the regulated industry, and the public. FDA was reluctant to discuss these issues in detail while the proposed rules were being developed and vetted within the agency.

Comments on the cGMP Proposed Rule are due December 22, 2009, and comments on the adverse event Proposed Rule are due December 30, 2009.