Drugs

FDA ‘Lean Management Process’ for Combo Products

FDA says it is launching a “lean management process mapping approach to build a better system for combination products review – one that’s more cohesive, more collaborative, and more systematic.” The process begins with an analysis of what’s being done currently, and then it designs a future process state that “eliminates waste and maximizes value,” according to an agency blog posting. The future process map, when complete, should show a streamlined, efficient process that will eliminate previously identified delays and redundancies, it says.

Lean management has already been successful in CDER’s Office of Clinical Pharmacology, where it helped establish project management staff functions, roles, and responsibilities for the office’s core processes. “The team also has applied its expertise to stand up the new Office of Pharmaceutical Quality, as well as apply its expertise to such topics as drug safety communications and risk evaluation mitigation strategy,” the posting says.

“Lean management works,” FDA says. “And we’re confident that applying lean management principles to combination product review will allow us to enhance communication and coordination among the groups that oversee the development, review, and approval of combination products. Of course, we realize that success in this area depends upon meaningful interactions among all FDA offices and Centers involved with combination products review. The active participation emphasized by lean management principles will ensure that the needed collaboration is present from the start.”

The lean process mapping is only the start for revamping combination product reviews, FDA says. More information about other key priorities and initiatives aimed at modernizing combination product reviews will be announced in the near future.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome