FDA Imaging Endpoint Guidance Tells Sponsors To Charter "Incidental Findings"
This article was originally published in The Pink Sheet Daily
Executive Summary
Industry is wary of any mandate to report incidental findings to patients and their doctors, worried that it may be “inappropriately delegating a new responsibility to practice medicine by sponsors.” Firms press the agency to revise draft document.
You may also be interested in...
Better Imaging Doesn't Always Mean Better Diagnosis, Expert Says
Overdiagnosis - the diagnosis of a disease more often than it is actually present - is a major problem stemming from the screening of more people with more advanced tools, asserts a Dartmouth College radiologist.
Janssen’s Sirturo Needs Minor Tweaks To Confirmatory Trial, FDA Panel Says
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.
Ranbaxy’s Atorvastatin Recall: Will Glass Shards Nick FDA’s Reputation?
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.