FDA issues final rule on safety information during clinical trials

 FDA is announcing a final rule that will improve the quality of safety reports and better protect people participating in clinical trials for drugs. The final rule clarifies the safety information that drug sponsors (drug manufacturers) must report to FDA for investigational new drug applications (INDs).
The final rule will help sponsors decide whether an adverse event that occurs in a participant during a clinical trial is related to the investigational drug being tested, or if it is related to other health problems in the trial participants. Reports that focus on the most significant adverse events help FDA, sponsors, and clinical investigators better understand how to use the drug safely. 
The final rule defines new terms that help clarify when an adverse event should be reported to FDA rapidly - within 7 to 15 days. The rule explains that adverse events should be reported to FDA in an expedited manner only when there is a reasonable possibility that the drug caused the adverse event. The final rule also makes clear what information should not be reported to FDA because the information would not help the agency assess the safety of the drug being studied. 
The final rule enhances the protection of clinical trial participants by requiring rapid reports to FDA of certain safety information that had not previously been required. For example, findings from clinical or epidemiological studies that suggest a significant risk or serious, suspected adverse reactions that occur more frequently than anticipated must now be reported rapidly to FDA.Another new requirement is that serious adverse events from bioavailability and bioequivalence studies, which are typically conducted for generic drugs, need to be reported rapidly to FDA.
Many clinical trials are conducted in countries outside the United States, so the revised definitions and reporting standards in this final rule are designed to be as consistent as possible with international definitions and standards. This should help lead to consistent, harmonized reporting for globally conducted clinical trials. Safety information from clinical studies conducted outside the United States can be evaluated along with information from U.S. clinical trials.

Reference:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm227386.htm