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FDA Stays Focused on Tracking Drugs After Approval
"We think we've really balanced this," Dr. Janet Woodcock, director of the agency's Center for Drug Evaluation and Research, told reporters attending the Association of Healthcare Journalist meeting in Atlanta.
In a report released on Saturday, the FDA says it has required companies to do 385 post-market studies since 2008, and to change the label based on new safety information 65 times.
Read the news story on Reuters.