FDA Drive to Develop Trial Data Standards Has NDA, BLA Implications

The FDA has released a plan detailing how the agency will develop and implement clinical trial data terminology standards for therapeutic areas (TA), an initiative that could affect drug and biologic application reviews. One of the performance goals under the reauthorization of PDUFA was to develop and implement common study data standards. The so-called TA Project Plan aims to address that goal.
Washington Drug Letter