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fishbone · drug-filing · approval-delay

Factors Affecting Approval Time in Drug Filing

Type Fishbone (Ishikawa)Standard Ishikawa (1968) cause-and-effectEngine schematex-fishboneUpdated 6/26/2026
Factors Affecting Approval Time in Drug Filing
Drawing preview
The request

“Create a fishbone diagram for drug filing approval time exceeding target with personnel, process, technology, regulations, and data causes.”

Then tryAdd reviewer capacity under Personnel.Change the effect to a delayed regulatory approval.
What is in this drawing

Read the decisions behind it.

01

Selecting relevant categories covering all aspects of the filing process

02

Prioritizing causes that directly impact timeline delays

03

Structuring the diagram to maintain clarity with indented sub-causes

This fishbone can be used in regulatory affairs improvement initiatives, root cause analysis meetings, and process optimization in drug development.

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