Clinical Trial Centralized Monitoring Shouldn’t Be Automatic, Industry Tells FDA
FDA needs to provide further clarification about how “centralized” clinical trial monitoring could work as a substitute for onsite monitoring, industry commenters say as they urge FDA not to move too fast towards a “risk-based” approach.
You may also be interested in...
Recent Duke University survey found that firms predominately conduct frequent visits to each clinical investigator site but "the rationale behind any specific monitoring approach does not appear to be evidence-based."
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.