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Home » SOME COMBO PRODUCTS SUBJECT TO cGMP AND QUALITY SYSTEM RULES
SOME COMBO PRODUCTS SUBJECT TO cGMP AND QUALITY SYSTEM RULES
September 30, 2004
Companies that manufacture single-entity or co-packaged combination products must adhere to manufacturing regulations governing both pharmaceutical products and medical devices, according to a draft guidance released Sept. 29 as part of the FDA’s pharmaceutical current good manufacturing practice (cGMP) initiative.