Where Do These Guys Come From?

In a series of FDA Safety Alerts, Recall Notices, and Enforcement Actions over the last couple of years, the Agency has notified consumers of dozens of OTC products that contain undeclared and dangerous drugs.

CMC Draft Guidance to Better Define Changes That Must Be Reported to FDA – Clear as Mud

Industry does not always get either the filing type or the need to file the change correct and, sometimes, due to an overabundance of caution, makes supplemental submissions when they may be able to either report the changes in an Annual Report or may not need to report the change at all, but manage it under their Pharmaceutical Quality System (PQS).