FDA Releases Guidance on CGMPs for Combination Products

The Food and Drug Administration issued a new guidance document (here) on current good manufacturing practices (CGMP) for combination products, it said (here). The guidance is intended to explain FDA’s January 2013 final rule that set CGMP requirements for combinations of drug, device and biologics products (see 13011824). The guidance also “includes general considerations for CGMP compliance as well as analysis of hypothetical scenarios,” FDA said.