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www.fdanews.com/articles/123683-proposed-combo-products-rule-underestimates-cost-of-gmps

Proposed Combo Products Rule Underestimates Cost of GMPs

January 14, 2010
The FDA’s proposed rule on good manufacturing practices (GMPs) for combination products underestimates the burden of applying certain cGMP requirements to drug-device combinations, industry says. Requiring companies to meet drug batch release requirements in lieu of a risk-based quality assurance program adds significant cost to the manufacture of each batch or lot produced and can be cost-prohibitive, Biotronik says in a comment on the rule.
Drug GMP Report