FDA Revises Guidance to Provide Clarification on Actions FDA May Take on an Application When the Agency Cannot Inspect a Facility Due to Factors Including Travel Restrictions FDA is providing additional information to drug manufacturers on circumstances under which the agency plans to approve an application, issue a complete response (CR) letter, or defer action when a site cannot be inspected due to factors including travel restrictions related to the public health emergency, and how FDA plans to prioritize inspections as travel restrictions are lifted. While the number of inspections that can be conducted by FDA during the COVID-19 public health emergency are limited due to travel restrictions, FDA intends to continue using alternative tools, when appropriate, to evaluate facilities. Decisions regarding applications will be based on the totality of the information available to FDA, including information obtained from use of the alternative tools, which may include remote interactive evaluations as described in FDA's recent guidance to industry. Based on an assessment of the product information provided in the application and based on available information about the facility or site, and as further explained in the revised guidance, FDA will take one of the following actions: | Planned Action | Facilities and Sites | Other FDA Drug Assessment Deficiencies | | Approve the application | Available information supports the adequacy of the facilities and sites named in a pending application | No deficiencies have been identified and the application otherwise satisfies the requirements for approval. | | Issue a CR letter with facility- or site-related deficiencies | Available information from a prior inspection or other source identifies deficiencies about the facility or site, but the required inspection cannot be completed due to factors including travel restrictions. | If any other deficiencies, are identified by the assessment team, the CR letter will include those deficiencies. | | Issue a CR letter without facility or site deficiencies | An inspection is necessary because there is a lack of information about the facility or site but cannot be completed due to factors including travel restrictions (a facility or site deficiency will NOT be issued in this case; the facility or site issue will be a comment in the CR letter). | Other deficiencies are identified by the assessment team. The CR letter will contain those deficiencies. | | Defer action (i.e., miss the goal date) | An inspection is necessary because there is a lack of information about a facility or site and cannot be completed due to factors including travel restrictions (a facility or site deficiency will NOT be issued in this case). | No deficiencies have been identified, and the application otherwise satisfies the requirements for approval. | For further information, please contact CDER-OPQ-Inquiries@fda.hhs.gov. FDA will continue to review comments submitted to the docket for this guidance. This information, plus information on how FDA will prioritize inspections and additional clarifications, 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. |
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