FDA Transparency Initiative Sees No Clear Path To Releasing Documents, Woodcock Indicates
This article was originally published in The Pink Sheet Daily
Executive Summary
Requirements to redact proprietary information from documents, make them accessible to the disabled, and other challenges would greatly tax FDA staff, FDA's Janet Woodcock says.
You may also be interested in...
FDA Transparency Initiative: Disclosure Rules Could Expand, Then Be Harmonized
Following the release of FDA's Transparency Task Force report, the agency may want to add an agenda item to its harmonization discussions with EMA
FDA Transparency Initiative: Disclosure Rules Could Expand, Then Be Harmonized
Following the release of FDA's Transparency Task Force report, the agency may want to add an agenda item to its harmonization discussions with EMA
Can FDA Do The "Right Thing" On Transparency? Ask A Lawyer
Proposals from agency task force include releasing when applications are submitted and withdrawn along with FDA reasons for refuse-to-file and complete response letters.