New and Revised FDA Filer Evaluation Outcomes for August

The Food and Drug Administration posted its updated list of filer evaluation outcomes for August 2018. The frequency of filer evaluations depends on the number of lines filed by the company. An outcome of "paperless" means FDA has determined that electronic filing is appropriate, while "corrective action plan" means FDA has found an elevated error rate and has directed the filer to fix the issue, and "dual-mode filer" means the company has failed to implement corrective action plans and has been returned to dual-mode (paper and electronic) filing. The following filer evaluation outcomes were updated in FDA's August 2018 list: