Oops! US FDA's Paperwork Submission Failure Leaves Audit Fixes Overdue
The FDA did not submit the form the Office of Inspector General needed to resolve audit findings, meaning two years of recommendations were considered overdue.
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FDA resolves audit issues
FDA has resolved outstanding audit recommendations and installed a protocol to resolve future recommendations according to a Feb. 15 1report from the Health and Human Services Office of Inspector General (OIG). OIG found that "FDA did not have reasonable assurance that it was exercising proper stewardship over Federal dollars" because, as of Dec. 31, 2005, the agency had not resolved eight audit recommendations out of 314 from 16 audit reports during calendar years 2003-2005. OIG says 287 of those 306 resolved were not completed within the required six months...
Is It Time To Promote US FDA’s Biosimilars Office Out Of OND?
Making the Office of Therapeutic Biologics and Biosimilars a stand-alone office in CDER may allow it to add more expertise, but is there an appetite for another reorganization?