FDA's Combo Product Consultations To Be Streamlined

Internal assessment finds inter-center collaboration stymied by issues ranging from IT compatibility to resource reimbursement, but FDA says it has a five-point plan to improve the process.

An internal assessment of FDA's inter-center consultations for combination products has found the process overly cumbersome, but FDA says it is already simplifying access to its IT system, revising instruction manuals, updating its organizational charts and putting out more guidance documents to address the concerns raised in the report.

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