FDA issues draft guidance on reporting CMC changes

FDA issued draft guidance advising pharmaceutical companies on which changes must be reported to FDA with respect to chemistry, manufacturing and controls information for approved drugs and biologics.

Sponsors must notify FDA, through a supplement or inclusion in an annual report, of any changes to CMC information that meet the definition of an "established condition." These include descriptions of the product, manufacturing process, facilities and equipment, and "elements of the associated control strategy" that assure process performance and quality of an approved product. ...