FDA TO LAUNCH A PILOT PROGRAMME TO MAKE FOR MAKING THE AGENCY’S DECISION-MAKING LESS OPAQUE
During a forum on FDA transparency, Commissioner Scott Gottlieb announced that the Food and Drug Administration is taking steps to make it easier for doctors, patients and researchers to get access to clinical trial data amassed during the process of approving new drugs.
The meeting focused on 18 recommendations for making the agency’s decision-making less opaque. The suggestions were part of a report called Blueprint for Transparency.
The FDA has long said it is sharply limited in what information it can release because it often is dealing with drug companies’ proprietary material, however this will start a pilot program to release portions of clinical study reports for recently approved drugs. The data will not include patient-identifiable information.
The commissioner also said the agency will make it easier to track clinical-research information by adding a study’s identifier number from ClinicalTrials.gov to all FDA materials for a specific product. ClinicalTrials.gov is the database of studies maintained by the National Instit ...