What is the difference between consultative and collaborative reviews of combination products?
When combination products are assigned to a lead Center, that Center may consult or collaborate with another Center as part of the review process. FDA has a Standard Operating Procedure for the intercenter consultative and collaborative review process. The SOP includes the definitions of consultative and collaborative reviews, and sets out the procedures, policies and processes for Agency staff to use when requesting, receiving, handling, processing, and tracking formal consultative and collaborative reviews of combination products, devices, drugs and biological products. The SOP is posted at http://www.fda.gov/oc/combination/consultative.html. A consultative review, which is the most frequent process used for the review of combination products by a Center other than the lead Center, is a review activity in which a reviewer in one Center requests advice from a reviewer in another Center on a specific question or issue raised in the review of a submission. The consultative review is use
When combination products are assigned to a lead Center, that Center may consult or collaborate with another Center as part of the review process. FDA has a Standard Operating Procedure for the intercenter consultative and collaborative review process. The SOP includes the definitions of consultative and collaborative reviews, and sets out the procedures, policies and processes for Agency staff to use when requesting, receiving, handling, processing, and tracking formal consultative and collaborative reviews of combination products, devices, drugs and biological products. A consultative review, which is the most frequent process used for the review of combination products by a Center other than the lead Center, is a review activity in which a reviewer in one Center requests advice from a reviewer in another Center on a specific question or issue raised in the review of a submission. The consultative review is used to assist the requesting reviewer in making appropriate regulatory/scien
