News Tagged ‘food drug administration

Avandia reviewer calls for changes in FDA drug approval process

The Avandia debacle has prompted a safety official from the Food & Drug Administration () to call for changes in the way medications are approved for use in the United States. The official, who reviewed the original approval application for , told the Journal of Care that the safety and effectiveness of experimental medications should be tested against existing drugs before they are approved. If such a testing protocol were to be adopted by the , it would mark a significant departure from the way most medications are granted approval in the United States.

Read the rest of this entry »