In early August, the U.S. FDA released the
draft guidance, CMC Postapproval Manufacturing
Changes for Specified Biological Products
To Be Documented in Annual Reports. This
draft guidance provides recommendations
to holders of biologics license applications
for specified products regarding the types of
minor changes that need to be documented
in an annual report. In particular, the document
outlines CMC controls for post-approval
changes the Agency considers to have
minimal adverse impact on product. Under
current regulations, such minor changes
must be documented in an annual report.
Comments are due Oct. 10.