US FDA’s Streamlined Drug Approval Packages Shine Less Light On Sponsor Interactions
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.
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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.
FDA Aims For Transparency In Releasing New Risk-Based Site Selection Model For Determining Who Is Inspected Next
US FDA explains new risk-based model for selecting manufacturing sites for inspection in US and abroad. By releasing information about the model, FDA aims to shed some transparency in its decision-making process.
Genentech's Hemlibra: Clinical Outcome Assessment Data Only Partially Swayed US FDA
Hemophilia A drug's labeling reflects data on physical function improvement because FDA deemed that portion of the Haem-A-QoL instrument fit for purpose, while other questions were viewed as insensitive to change or irrelevant. Review documents suggest agency was unimpressed with results from a health status instrument frequently used in economic analyses.