FDA's Combo Product Consultations To Be Streamlined
This article was originally published in The Pink Sheet Daily
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.
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Industry is eagerly awaiting guidance on combination products, and after seven years the postmarketing reg may be at top of the agency’s queue.
FDA would be directed to test the concept of joint drug/device/diagnostic reviews in at least one therapeutic area; idea of further integrating medical product reviews is also part of Vice President’s cancer 'moonshot.'
FDA's concepts for new pathway could be ready for congressional scrutiny within a year.