Compounding Chief Departing US FDA After Leading Office Through 'Tumultuous Times'
Julie Dohm, who led a wide range of initiatives to bolster FDA's oversight of compounding pharmacies, will be joining Covington & Burling after leaving the agency March 29. A replacement has not yet been announced.
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Grail Sipes, CDER deputy center director for regulatory policy, will move to the Executive Office of the President next month.
After discovering one firm suppressed over 4,000 compounded-hormone adverse event reports, agency leans on compounders and outsourcers to improve reporting.
The US FDA plans to give its young drug compounding oversight program new leadership and move it from the drug center director's office down to the center's compliance office. Whether this move translates into heightened enforcement of drug compounders remains to be seen.