FDA Implements New Regulation to Improve Safety Reporting in Clinical Drug Trials

By Blume Forte Fried Zerres & Molinari on July 21, 2011

According to The New England Journal of Medicine, the U.S. Food and Drug Administration (FDA) has recently initiated new regulations concerning drug safety reporting. The regulations establish a new safety reporting paradigm for new drugs under investigational applications (INDs). These new regulations are expected to help protect human subjects as well as improve conduct during clinical trials.

The new FDA regulations clarify how unexpected adverse incidents potentially caused by a new drug should be reported and analyzed. They also provide more guidance on casualty assessment, which is needed to determine the role the drug played in the adverse incident. Furthermore, clinical investigators must now report any and all adverse incidents to the IND sponsor, whether they are believed to be drug-related or not.

Monitoring the safety of human subjects during clinical trials is crucial to the proper development of any drug. It is essential to protect clinical trial volunteers, in addition to identifying adverse side effects of the drug. Although safety databases are thoroughly examined once marketing approval is sought, ongoing and appropriate safety monitoring during clinical trials would ensure that serious adverse reactions are discovered as soon as possible.

Regulations are an important step in preventing dangerous, contaminated, and misrepresented drugs from entering the market, but until all pharmaceutical companies and drug developers consider patient and consumer safety above profits, many more drugs may be recalled, and many more people harmed.

If you or a loved one has suffered injury or illness due to a dangerous drug in New Jersey, you may be entitled to compensation. At Blume Forte, our experienced New Jersey unsafe drug lawyers have handled numerous pharmaceutical litigation claims and can help you determine whether you may have a meritorious claim arising out of an adverse drug reaction or side effect. Contact us at 973-635-5400 to learn more about your rights.

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