Zdrowie i gospodarka · 28/10/2002

FDA Regulation of Combination Products; Public Hearing

The Food and Drug Administration (FDA) is announcing a public hearing to discuss the assignment, premarket review, and postmarket regulation of combination products. Combination products (defined in more detail later in this document) are products containing a combination of drugs, devices, or biological products. These products often are novel and have significant potential to enhance the public health. The purpose of the hearing is to solicit information and views from interested persons on the issues and concerns relating to the assignment, premarket review, and postmarket regulation of combination products. FDA is proposing specific questions, and the agency is interested in responses to these questions and any other pertinent information stakeholders would like to share.