On September 23, 2009, the Food and Drug Administration issued a proposed rule in the Federal Register to codify which quality requirements will apply in the manufacture of certain combination products (e.g., a combination of a drug and a medical device). 74 Fed. Reg. 48,423; Proposed 21 C.F.R. Part 4, subpart A. Specifically, the proposed rule attempts to streamline and clarify the regulatory framework that firms may use to demonstrate compliance with quality requirements for “single-entity” (i.e., combination products that are physically, chemically, or otherwise combined or mixed and produced as a single entity) and “co-packaged” (i.e., combination products that are packaged together in a single package or as a unit) combination products.
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