This post was written by Paul Sheives.

FDA is requesting comments on a draft guidance document that proposes some types of chemistry, manufacturing and controls (CMC) post-approval manufacturing changes that may be reported in the annual reports.  FDA bases the timing requirements for certain reportable information on the level of risk presented to product quality by the change.  The types of changes listed in the guidance for which FDA believes the risk justifies reporting annually include certain changes to components and composition, manufacturing sites, the manufacturing process, specifications, container/closure systems and other miscellaneous changes.  Comments on the draft guidance may be submitted until September 23, 2010.