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US FDA's Benefit/Risk Framework Gets High Marks But Could Be Improved

 
• By Sue Sutter

Agency summaries contained in reviews of novel drugs and biologics are useful and informative but difficult to find, and their use should be expanded to other types of applications, industry sponsors and other external stakeholders say.

FDA Approved typed words on a vintage typewriter

The US FDA's benefit/risk assessment framework effectively explains agency approval decisions on new drug and biological applications and is useful for product sponsors in their drug development programs, but the agency should take steps to expand their use and increase their availability, a consultant's report concludes.

"The benefit/risk framework was successful in communicating the reasoning behind FDA's regulatory decisions, useful and worthwhile to various audiences, and [was] clear and understandable to most audiences," said Valerie Overton, vice president of Eastern Research

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