Scientific and regulatory review process for medical devices (1)
Posted on March 31st, 2010 in Digital Camera Batteries, Uncategorized, battery news, laptop battery site | No Comments »
Scientific and regulatory review process for medical devices (1)
A former Food and Drug Administration scientist said Tuesday his job was eliminated after he raised concerns about the risks of radiation exposure from high-grade medical scanning.
After FDA officials pushed ahead with plans to clear the device, Nicholas, now a physician at the Scripps Clinic in San Diego, said he and eight other staffers raised their concerns with the division’s top director Dr. Jeffrey Shuren last September. The Dell C1295 battery device apparently is still under review.
“Scientific and regulatory review process for thinkpad t60 battery medical devices was being distorted by managers who were not following the laws,” Nicholas said. A month later Nicholas’ position was terminated, he said.Nicholas does not think there was undue influence by the manufacturer in his ouster, but that his more cautious stance was in opposition to that of FDA higher-ups.
The allegations about suppression of scientific dissent come at an inopportune time for the agency.Hundreds of studies have linked certain types of radiation, including the type used in medical imaging of Dell inspiron 1521 battery , to cancer that can surface decades later.
FDA medical reviewer Dr. Robert Smith, a colleague of Nicholas who also presented at Tuesday’s public meeting, said he hoped the FDA would learn a lesson from Nicholas’ testimony to Dell latitude d420 battery .”Science must not be ignored, suppressed or distorted as that endangers the public,” Smith told the audience.Smith, who still works for the agency, supported Nicholas’ conclusion that CT scanning for colon cancer should be rejected on safety grounds.
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