Current Edition

Data Compliance or Rejection – Are you ready for September 15th?

Until recently sponsors have been able to submit nonclinical and clinical reports without datasets and without fear of rejection. In less than three months, the agency will begin to enforce their Technical Rejection Criteria for Study Data: “FDA plans to implement eCTD validation checks when submissions contain content under modules 4 and 5 beginning September 15, 2021. Submissions which fail this validation will be subject to rejection.” Melissa Rapp at Pharmalex analyses what are the impacts of this incident in the industry and why it is so important to the agency.