Did You Know?

For Pharmaceutical and Biologics companies that organize or participate in clinical trials, final rules issued by the FDA can have a significant impact on policies and procedures related to the implementation of a clinical trial. A recently issued final rule addresses how and when safety information must be reported.

For example, instead of demanding that ALL adverse events be reported at all time, the new final rule provides examples of events that should be reported and of events that do NOT need to be reported until the event has occurred a second time. These new examples and definitions will allow FDA representatives to more clearly organize and structure adverse events information. Also, according to an FDANews release the following additional requirements are also explicit within the rule's text:

• "findings from clinical or epidemiological studies that suggest a significant risk to study participants"
• "serious suspected adverse reactions that occur at a rate higher than expected"
• "serious adverse events from bioavailability studies which determine what percentage and at what rate drug is absorbed by the bloodstream and bioequivalence studies which determine whether a generic drug has the same bioavailability as the brand name drug"

Goals

Goals for the implementation of these new requirements includes the increased safety of clinical trial participants and an improvement in the harmonization of FDA regulations with the regulations of the International Conference on Harmonization and the World Health Organization.

See Full Text of Final Rule

To see the full text of the Final Rule please visit: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm226358.htm