Emeryville, CA (Vocus) October 6, 2010
BioSoteria, Inc., Drug Safety and Risk Management Specialists, responded to the recent announcement of the ruling by FDA on safety information during clinical trials. The FDA has announced changes to the regulations on IND safety reporting, which go into effect on March 28, 2011. To read more about our review and interpretation of this Final Rule and how these regulation changes will impact your clinical trial conduct and IND safety reporting practices, go to BioSoteria News & Events and download BioSoteria’s White Paper on the FDA Final Rule.
The new rule requires that certain safety information that previously had not been required to be reported to FDA be reported within 15 days of becoming aware of an occurrence. These reports include 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 described in the investigator brochure; and serious adverse events from bioavailability and bioequivalence studies. The rule also provides examples of evidence to guide study sponsors in determining which adverse events should be considered expected. Additionally, the Final Rule revises definitions and reporting standards to be more consistent with harmonized international standards set by the International Conference on Harmonization (ICH). Along with this final rule, the FDA also issued a draft guidance for industry and investigators that provides information and advice about the new requirements.
Founded in 2007 with a strong vision of a progressive drug safety and pharmacovigilance consulting services and education, BioSoteria serves the outsourcing needs of the pharmaceutical industry. From strategic risk management consulting services and full-service drug safety operational capabilities to world-class award winning pharmacovigilance training and education programs, BioSoteria provides unmatched experience, expertise, and leadership to support your company’s efforts to maximize your product’s benefit-risk profile. For more information about BioSoteria and our safety consultative and training services, go to http://www.biosoteria.com.