FDA Issues Final Rule on CGMP for Combination Drug, Device & Biological Products
The Food and Drug Administration issued a final rule clarifying application of current good manufacturing practice (CGMP) requirements to combinations comprised of drugs, devices, and/or biological products. Depending on the form of combination, CGMP requirements will: (1) apply to each…
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constituent part separately; or (2) satisfy CGMP or quality system regulation requirements for another constituent part if applied to one constituent part. The final rule is effective July 21.