FDA Introduces the Pre-RFD ProcessMaking continuous improvements in the combination products program
Thu, 08/25/2016 - 16:43
One question that product sponsors often ask the U.S. Food and Drug Administration (FDA) is whether their medical product will be regulated as a drug, a device, a biologic, or as a combination product—and in the case of the latter, which FDA… Addressing Human Factors Relating to Combination ProductsFDA seeks comments on new draft guidance
Tue, 04/12/2016 - 13:30
Combination products represent an important and growing category of therapeutic and diagnostic products under the U.S. Food and Drug Administration’s (FDA) regulatory authority. These products, which combine a drug, device, and/or biological product…
