Combination Products Raise Manufacturing Challenges

Combination medical products are hot and becoming hotter. In January, the Food and Drug Administration made headlines by quickly approving a fixed-dose-combination (FDC) treatment for AIDS under a new policy that allows its use in developing nations. Pharmaceutical manufacturers also are building commercial markets at home by developing FDCs offering clinical benefits and/or reduced risk while also improving patient compliance and extending the life cycle of established therapies. A related FDA initiative clarifies regulatory policies for products that combine drugs, biologics, and medical devices and thus are regulated by multiple agency centers. FDA’s Office of Combination Products (OCP) is crafting rules and guidances to govern which FDA center will lead the regulation of new combinations and what manufacturing and compliance policies will apply. The process involves clarifying manufacturing standards, postapproval changes, user-fee requirements, and a host of other issues.



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