FDA issues pandemic inspections FAQ guidance
Posted 19 August 2020 | By Michael Mezher
The US Food and Drug Administration (FDA) on Wednesday issued an immediately effective frequently asked questions guidance explaining its approach to inspections and manufacturing and supply chain changes during the coronavirus disease (COVID-19) pandemic.
For the time being, FDA says it is still following the approach to resuming domestic inspections it laid out last month and will continue to postpone non-mission-critical foreign pre-approval and for-cause inspections. (RELATED: FDA looks to resume domestic inspections this month, Regulatory Focus 10 July 2020).
For domestic inspections, this means conducting mission-critical inspections on a case-by-case basis or, when it can be done safely, resuming domestic inspections based on priority.
“With respect to pre-approval inspections, FDA intends to continue using other tools and approaches where possible, including requesting existing inspection reports from other trusted foreign regulatory partners through mutual recognition and confidentiality agreements, requesting information from applicants, and requesting records and other information directly from facilities and other inspected entities,” FDA explains.
FDA also explains how it determines whether an inspection is mission critical. Among the factors the agency considers are whether a product has a breakthrough therapy designation or regenerative medicine advanced therapy (RMAT) designation, or is used to diagnose, treat or prevent a serious disease without an appropriate therapeutic alternative. The same factors apply to FDA’s decision-making for both foreign and domestic inspections.
FDA notes that both for-cause and pre-approval inspections can be deemed mission critical and that it will consider the safety of its staff and employees at the site, as well as clinical trial participants and patients when deciding whether to conduct an inspection.
In situations where travel restrictions prevent FDA from conducting preapproval inspections, FDA says it will not automatically issue a complete response letter for the application and that any decisions related to an application will be based on the totality of information available to the agency.
FDA says that if it determines an inspection is necessary for approval because it has concerns about the adequacy of the facility it will notify the applicant as early as possible. “If the inspection of a facility that raises such concerns has not been completed by the action date, FDA generally intends to issue a complete response letter.”
Where the agency does not have enough information to make a determination about a facility, FDA says it may defer action on an application until it can conduct an inspection.
Manufacturing and supply chain changes
FDA also addresses issues related to manufacturing and supply chain changes for already approved products.
Drugmakers looking to add or change a facility in an application due to supply chain disruptions caused by COVID-19 are instructed to refer to FDA’s established guidance on the matter. However, for drugs and biologics used to treat or prevent COVID-19 and products currently in shortage, FDA says submissions should state “Priority Review Requested” and contain information to support the request.
Similarly, FDA says drugmakers looking to make manufacturing process or facility changes in response to the pandemic should refer to existing scale up and postapproval change guidance and notes that companies should reach out to the Center for Drug Evaluation and Research’s Office of Pharmaceutical Quality or the responsible office within the Center for Biologics Evaluation and Research to discuss atypical or flexible submission strategies.
FDA says it is “willing to consider requests from applicants to submit certain changes using a lower reporting category” with adequate risk-mitigation information for drugs and biologics intended to treat or prevent COVID-19 or that are in shortage.