FDA Interim process for communicating findings from 704(a)(4) record requests FDA is implementing an interim process to communicate issues identified following a review of records or other information requested under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in lieu, or in advance, of a Pre-Approval or Pre-License Inspection for CDER regulated products. The agency intends to communicate issues to facility representatives following the completion of its review of records or other information requested under section 704(a)(4) of the FD&C Act. The agency plans to consider any formal responses regarding these issues prior to taking an action on a pending application impacted by these issues, as feasible given user fee agreement and internal review program milestones. The interim process will be implemented for the remainder of the COVID-19 public health emergency and evaluated periodically, revised as needed, and may be expanded to record request processes in lieu or in advance of other drug inspection programs (e.g., routine surveillance). This information, as well as additional information on Mutual Recognition Agreements, has been included in the revised guidance, "Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers," and posted to FDA's web page, Manufacturing, Supply Chain, and Drug Inspections – COVID-19. For further information, please contact CDER-OPQ-Inquiries@fda.hhs.gov. |
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