US FDA May Scrap Clinical Study Report Disclosure For New Drug Approvals
Executive SummaryThe pilot project former Commissioner Gottlieb championed found only one sponsor interested in participating.
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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.