Postmarket Safety

FDA Extends Comment Period on Generic Safety Labeling Rule

The FDA has extended by 60 days the comment period for its proposed safety labeling rule for generic drugs. Stakeholders now have until March 13 to comment on the proposal, which would allow generic drugmakers to update labels in response to safety issues without agency approval. Read More

EMA Postpones Clinical Trial Transparency Plan Indefinitely

The European Medicines Agency (EMA) has indefinitely postponed a controversial plan to begin releasing to the public detailed information from clinical study reports contained in new drug applications, the central element to its clinical trial transparency initiative. Read More