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Industry: Email Alert RSS FeedThe new FDA Combination Products Programme: the United States (US) Food and Drug Administration (FDA) has established a Combination Products Programme and developed a new internal procedure to increase its effectiveness in regulating products consisting of combinations of drugs, devices and biological products.
Medical Device Technology, October, 2002 by Donawa, Maria E.
This article provides a brief overview of the FDA regulation of combination products and discusses the new Programme. (regulation and standards column) Combination product regulations The Food and Drug Administration (FDA) has recognised for some time that the review and approval of products consisting of combinations of drugs, devices and biological products has presented unique challenges and uncertainties on the most appropriate regulation of these products.
These uncertainties have sometimes led to excessively long delays in the review and approval of combination products. In some cases, companies have received contradictory opinions from various sources within FDA regarding applicable rules and regulations. To address these issues, FDA...
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