FDA Stays Focused on Tracking Drugs After Approval
The U.S. Food and Drug Administration said on Saturday it now spends as much effort and resources on surveilling a drug after it is approved as it does in the pre-approval process. The FDA was responding to critics who say the agency is toothless when it comes to tracking the safety of drugs already on the market, when industry funds that supported pre-approval reviews tend to dry up.
"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.