US FDA May Scrap Clinical Study Report Disclosure For New Drug Approvals
The pilot project former Commissioner Gottlieb championed found only one sponsor interested in participating.
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Of the two main contenders to lead FDA, Josh Sharfstein is seen as much more likely to open up review decisions to public scrutiny, while Janet Woodcock might be a vote for the status quo and more deferential to industry concerns.
US FDA's plan to post CSRs may also inadvertently release confidential commercial information, agency is warned by industry groups.
Interdisciplinary review template provides efficient summaries of data, but without the insight into regulatory thinking made possible by disclosure of decisional memoranda, subject area reviews, and meeting minutes.