Current Good Manufacturing Practice Requirements for Combination Products
On September 23, 2009, the FDA published a proposed rule to codify current good manufacturing practice (cGMP) requirements that apply when drugs, devices, and biological products are combined to create a combination product. In addition, the proposed rule sets forth what the FDA characterizes as a “transparent and streamlined” regulatory framework for demonstrating compliance with cGMP requirements for “single-entity” and “co-packaged'” combination products. The FDA is accepting comments on the proposed rule until February 5, 2010 (extended from December 22, 2009).
