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New and Revised FDA Filer Evaluation Outcomes for August
August 2, 2018 |FDA

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:

FDA Sets Fees for Import and Facility Reinspections for FY19; Invoices Remain on Hold
July 26, 2018 |FDA

The Food and Drug Administration set potential fiscal year 2019 fees for import reinspections, domestic and foreign facility reinspections, and recall activities performed by FDA if a firm fails to comply with a mandatory recall order, though it still isn't invoicing for services associated with the fees, it said in a notice. The agency set FY19 fees of $253/hour for domestic services involving travel and $282/hour if foreign travel is required. The fees are effective Oct. 1.