Reducing Waste In Combo Product Reviews: FDA Goes Lean
This article was originally published in The Gray Sheet
The agency disclosed plans to leverage "lean" management techniques, frequently employed in the private sector and by health care organizations, to streamline the process for reviewing new combination products.
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Top FDA officials, including CDRH Director Jeffrey Shuren and FDA Deputy Commissioner Robert Califf, are sending strong signals that the designation and review processes for combination products are due for a significant reassessment. That should be a priority topic of upcoming user fee negotiations with industry, they say.
Formal consultations between FDA's product centers are becoming more frequent, and they are often triggered by questions about human factors issues, says Office of Combination Products Director Thinh Nguyen.