CVM CMC Two-Phased Submissions

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] In late August, FDA released a guidance, “Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections” – finalizing an October 2014 draft – which provides recommendations to sponsors submitting CMC data submissions to CVM to support approval of a new animal drug or abbreviated new animal drug. The two-phased process allows for two separate CMC submissions, each with its own review clock, and each including complete appropriate CMC information that is available for review at the time of submission. The guidance specifies the technical details of how the process works, the review clocks, the information that is appropriate for each technical section submission, and the possible review outcomes. The guidance also includes CVM’s recommendations for meetings between the Division of Manufacturing Technologies and the sponsor during this process to ensure concurrence with the approach used for the CMC technical section.
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