The FDA is now requiring more notification of safety problems by drug manufacturers. The drugmakers will have 15 days to report serious adverse events according to a new rule. Drugmakers studying experimental drugs in anticipation of sales in the U.S. must now tell regulators about serious health problems that arise during clinical trials within about two weeks. This is a badly-needed change and it will help streamline safety monitoring.
The Food and Drug Administration, in the new rule, called on companies to report problems such as serious side effects that occur more often than anticipated to the agency within 15 days. Rachel Behrman, associate director for medical policy at the FDA’s Center for Drug Evaluation and Research, said the rule would help “expedite FDA’s review of critical safety information and help the agency monitor the safety of investigational drugs and biologics and these changes will better protect people who are enrolled in clinical trials.”
The rule offers companies specific guidelines and examples of what to report and when. In theory, drugmakers must present the FDA with data that shows their medicines are safe and effective to win approval. I’m not so sure that this has always been the case. Hopefully, the FDA is doing a better job in its regulatory capacity and we are making sure nothing falls through the cracks when it comes to safety.
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