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