The 21st Century Cures Act ushers in significant changes to the regulatory review of drug/biologic/device combination products. The regulation of combination products has been somewhat unpredictable and muddled over the last...more
On January 11, 2017, the U.S. Food and Drug Administration (FDA) issued a final guidance document entitled “Current Good Manufacturing Practice Requirements for Combination Products.”[1] This guidance describes and explains...more