Regulatory Briefings: FDA's "Internal Advisory Committees"

When FDA reviewers need help on a tricky regulatory question, they get advice from top-level officials at an internal meeting called a regulatory briefing. Many sponsors don't even know they exist. But at a time of change in review procedures and staff, companies need to learn how FDA's "internal advisory committees" work.

By Kate Rawson

Once a week, top officials from the Food & Drug Administration’s Center for Drug Evaluation & Research gather for a...

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