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
Drug GMP Report