MAPP 5200.7 Rev. 1 Issued Regarding Filing Review for Certain Amendments and Supplements
FDA released Revision 1 to its November 12, 2015 Manual of Policy and Procedures (MAPP) 5200.7 which contains “minor clarifications and formatting”, and added Attachment 2 – Work Guide for Prior Approval Supplements: Requirements for a Filing Review. Just a reminder that a MAPP is a document that provides a transparent view into how the […]