US FDA's Integrated Review Document Would Dramatically Downsize Public Information
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.
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The pilot project former Commissioner Gottlieb championed found only one sponsor interested in participating.
CDER is no longer proactively posting mid- and late-cycle meeting minutes and certain correspondence with sponsors for new drug and biologic approvals; drugs center says it is focused on ensuring the most scientifically meaningful information is prioritized and posted in a timely manner, but some observers say the change raises transparency concerns.
Keeping Track: A Lawsuit-Driven Complete Response Letter, A Refuse To File Letter, And Some Good News
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker