Sponsor-FDA Communications In IND Phase Will Get Outside Review

US FDA seeks White House approval for to contract for interviews with 100 to 150 active commercial IND holders.

FDA entrance sign 2016

The US FDA is ready to assess and potentially improve its drug development communication practices after similar efforts related to the application review process, another addition to a growing list of efforts to improve transparency.

The agency wants to hire Eastern Research Group (ERG), which has conducted several similar studies of FDA practices, to look...

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