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Comment Deadline: FDA Draft Guidance for Drug Products Containing Nanomaterials

  • Agency
  • Industry
  • Nanotechnology

The Food and Drug Administration (FDA) is seeking public comments regarding its draft guidance documents for applicants with drug products that contain nanomaterials. The FDA acknowledges that it evaluates nanomaterial-containing drug products on a case-by-case basis and uses a risk-based approach.  The FDA clarifies how applicants should approach nanomaterial analyses and integrate their findings throughout manufacturing processes and product development.