FDA To Be More Vigilant About Proposed Clinical Trial Exclusions
FDA’s Bob Temple says “document” being drafted will instruct reviewers to pay more attention during sponsor meetings and eliminate unnecessary exclusions from protocols.
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Labeling Would Include More Subgroup Findings Under Revised Guidance
FDA’s updated draft on clinical pharmacology says some specific population data should be included in labeling, regardless of whether response differences were found.
Failed Pediatric Study Data To Get FDA Review At Patient Meeting
Agency officials plan discussion of how analysis of failed pediatric clinical trial data can improve future trials during annual patient network meeting.
The Sound Of Silence: FDA Ponders How To Label When No Subgroup Difference Found
Clinical trial diversity meeting may broach the subject of whether drug labels should indicate that subgroup differences were explored, but none found.