The United States Food and Drug Administration on 28-09-2010 has revised and issued its final rule for reporting an adverse reaction or adverse event in any clinical trial , where in earlier rule it was not mandatory to report certain adverse reaction or adverse event .
This rule has made it mandatory for a sponsor or investigator of a clinical trial to report with in 15 days of becoming aware about adverse reaction or adverse event.
The reports should include following findings.
1.Findings from clinical or epidemiological studies that suggest a significant risk to study participants
2.Serious suspected adverse reactions that occur at a rate higher than expected
3.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
This rule also specifies with example about when one should immediately report an ADR or ADE to US FDA and when one should wait till next event to be observed so that it will clarify all questions and drought amongst sponsors or investigators of a clinical trial of a of investigational drugs and biologics.
US FDA has also made it mandatory to report all adverse reactions and adverse event to be reported while performing, bioeqivalence study for ANDA and .Bioavailability and pharmacokinetic studies and any epidemiological study which suggest that the adverse reaction or adverse event may cause serious harm to public health.
It is one of the remarkable steps towards ensuring public health, in some of latest happening.
This final rule will make easier for US FDA to review of critical safety information and help them to monitor the safety of investigational drugs and biologics
These changes will be able to protect health of people participated in a clinical trials, also in new rule some definitions and reporting standards are also revised so as to make them more consistent with those by ICH (International organizations, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use ) and the World Health Organization’s Council for International Organizations of Medical Sciences. The new rule is made to ensure harmonized reporting of globally conducted clinical trials.
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