Last month, FDA announced the beginning of its intercenter consult request process that will be piloted across the Agency through 2017. The pilot, which is part of FDA's larger efforts to improve and streamline the review of combination products (i.e., products that combine drugs, devices, and/or biological products), will: (i) establish timelines, specific to center and submission type, for identifying products as combination products and issuing and completing consults needed to support the review; (ii) develop a tiered consult approach that streamlines interactions across centers; (iii) define clear roles and responsibilities for the centers and offices involved; and (iv) create a standard, semi-automated, user-friendly intercenter consult request form that is managed electronically to ensure that users always have the most updated version and that all forms are tracked through a single system. The pilot began on August 1, 2016, and will proceed in three phases. FDA plans to collect data throughout the program to evaluate its success and refine processes, procedures, and training for subsequent phases as needed.
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