Post by icemandios on Sept 21, 2016 15:37:56 GMT
Under the present work load, the FDA is attempting to work through a 2 year backlog of "Abbreviated New Drug Applications" (ANDA). This might lead one to wonder what is "abbreviated" in that process?
Now, the FDA wants to approve all "Laboratory Developed Tests (LDT) which currently are permitted under the Clinical Laboratory Improvement Act (CLIA).
4Kscore is a CLIA test.
And the proposal is being touted as a means of "ensuring" the tests are safe and accurate and unlikely to cause harm to patients.
On that score, the FDA clearly has failed given the number of FDA approved drugs that have been recalled after being approved, many of which have been the subject of class action lawsuits by patients and/or the patients' survivors who have been harmed.
Likewise with FDA approved medical devices, not the least of which was the Johnson & Johnson/Dupuy hip replacement debacle. There is no evidence that FDA approval "ensures" patient safety.
This is a 2 hour Senate hearing on the FDA proposal, and I would strongly recommend watching and listening.
Now, the FDA wants to approve all "Laboratory Developed Tests (LDT) which currently are permitted under the Clinical Laboratory Improvement Act (CLIA).
4Kscore is a CLIA test.
And the proposal is being touted as a means of "ensuring" the tests are safe and accurate and unlikely to cause harm to patients.
On that score, the FDA clearly has failed given the number of FDA approved drugs that have been recalled after being approved, many of which have been the subject of class action lawsuits by patients and/or the patients' survivors who have been harmed.
Likewise with FDA approved medical devices, not the least of which was the Johnson & Johnson/Dupuy hip replacement debacle. There is no evidence that FDA approval "ensures" patient safety.
This is a 2 hour Senate hearing on the FDA proposal, and I would strongly recommend watching and listening.
