Biomarker Qualification Draft Guidance From FDA May Itself Need Refining
Biomarkers in bodily fluids and tissue samples raise different questions, so the FDA draft guidance on the use of histology to qualify them should make the distinction clearly, Sandra Gaston, Harvard Medical School, said.
You may also be interested in...
FDA’s proposed process for qualifying drug development tools allows for the convening of advisory committee meetings or other public discussions about complicated submissions involving proposed biomarkers or patient-reported outcome instruments.
Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.
Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.