The agency is collaborating with research institutes and other organizations to:

• Improve the ability of animal testing to detect and predict organ damage.
  
• Increase identification of toxicity problems during clinical development programs.
  
• Improve the ability to understand whether less serious problems observed in small populations predict rare serious adverse events with broader exposure.
  
• Create understanding of the mechanisms of adverse events to encourage development of screening tests to prevent exposure of individuals susceptible to adverse events.
  

Figure 13 summarizes drug review, from test tube to market approval. Throughout clinical trials, the FDA’s Division of Scientific Investigations (DSI) inspects investigators’ study sites to verify the quality and integrity of clinical trial data submitted by manufacturers.

Investigators check to verify that a study is conducted according to investigational plan, that diverse events are recorded, and that subjects meet inclusion/exclusion criteria outlined in study protocol. The Center for Drug Evaluation and Research (CDER) conducts about 300 to 400 clinical investigator inspections annually.

After clinical studies are complete, a specially trained FDA review team evaluates the manufacturer or sponsor’s research. This team consists of medical doctors, chemists, statisticians, microbiologists, pharmacologists and other experts.

The research findings need to address such questions as: Does it show the drug to be safe and effective for its proposed use? Do the benefits of the drug outweigh the risks? This review process includes an evaluation of drug labeling to determine if directions for use are adequate.