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
Revised Q & A can be found at below link:
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 action describe in Question no 6 of Q & A document.