FDA IRB Crackdown Garners Praise From Former Chief Counsel Hutt
This article was originally published in The Pink Sheet Daily
Coast IRB investigation “shook up IRBs,” Hutt says during BIO panel, “which is good.” Former Deputy Commissioner Torti, Penn’s Fitzgerald note dangers of excessive regulation of IRBs.
You may also be interested in...
Many large and small drug firms are clients of Coast IRB, which was caught approving a fraudulent study.
US FDA’s workshop to discuss new ideas to assess the impact of the opioid REMS comes after the industry collaboration behind the REMS has deemed the task essentially impossible.
Whether CME for pain management has the intended impact on prescribing is likely focus of new ‘suite of studies’ intended to assess the opioid REMS program. The challenges for FDA include teasing out the impact of the risk management program amid all the other public health efforts on opioids.