Drug/device combos
Executive Summary
Public hearing slated for Sept. 6 by FDA "to give all interested persons the opportunity to provide comments and suggestions about the content and scope of the procedural regulation" of device, drug or biologics combinations. FDA Ombudsman Amanda Pederson will chair the public hearing. The Safe Medical Devices Act of 1990 requires that a regulation for combination products be promulgated by Nov. 29.
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