CDER’s Office Of Pharmaceutical Quality Remains A Wild Card
Few details have been released about proposed new office that was part of the reason the Office of Generic Drugs director resigned.
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Rachel Sherman says agency is creating patient affairs staff, but will not undergo reorganization to create an official office.
Another outside candidate is expected to eventually take over for the departing director Gregory Geba, and while the Office of Generic Drugs can run smoothly without a permanent leader for now, it cannot do so forever.
Brookings’ Engelberg Center for Health Care Reform invited to help FDA research REMS and risk-benefit standardization, patient-reported outcomes, and other issues that were mandated in PDUFA V.