FDA aims to cut risk of clinical trials
The Food and Drug Administration is laying down new rules for clinical trials and how they report potentially dangerous defects in drugs they are evaluating.
The new regulations handed down by the FDA will make the reports required of clinical trials more comprehensive in how they document risks and speed up the timeline in which these reports must be filed.
Pharmaceutical companies must now report to the FDA within 15 days of becoming aware of certain risk factors.
Companies must report any results from a epidemiological or clinical study that indicate risk for study participants. Companies must also report if certain side effects, which may have been expected, are occurring at a higher rate than expected. The changes to the U.S. regulations will also affect how drug absorption rates are reported and document any differences between generic and name brand drugs.
Many of these changes will make U.S. regulations more consistent with international regulations developed by the World Health Organization.
In recent years, there have been several high profile studies done demonstrating dangerous side effects of popular drugs. Prempro, a hormone replacement for women; Trasylol, a blood clotting agent; and Avandia, a diabetes treatment, have all recently come under scrutiny after the potential for dangerous side effects were reported for each drug.
