FDA has issued temporary guidance for pharmaceutical companies seeking to implement manufacturing and site changes as part of an application, as well as provided information as to how the agency will approach Complete Response letters during the COVID-19 pandemic.
In a recently released Manufacturing and Supply Chain Change Requests Q&A, FDA has indicated that “Priority Review Requested” should be clearly indicated on the submission cover letter for changes to production facilities for treatment products related to COVID-19 or products on the FDA drug shortage list. All other submissions should use established guidance.
Additionally, FDA is utilizing additional tools to determine whether the need for an on-site inspection to support the application assessment is warranted. These additional tools include reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements, and requesting records “in advance of or in lieu of” on-site drug inspections.
EAS Consulting Group offers records reviews for drug firms submitting applications to FDA. These reviews include ensuring complete and accurate data and identifying any gaps or corrections that must be addressed prior to FDA review. Additionally, EAS assists foreign drug firms by acting as their FDA U.S. Agent.
Finally, FDA continues to ensure safe products despite limited in-person facility inspections during COVID-19 pandemic. Some of the steps to accomplish this include denying entry into the U.S. for unsafe and inferior quality products, physical examinations and sampling of products arriving at U.S. borders as well as testing products prior to release into commerce.
Should your products be detained upon import, contact EAS for assistance. Our independent consultants include experts in drug GMPs, labeling and submissions, as well as former FDA and CBP officials, with an in-depth understanding of the import process, who can assist with determining the cause of detention and expedite release. We look forward to assisting you.
Regards,
Bryan J. Coleman
Senior Director for Pharmaceutical and Device Consulting Services
bcoleman@easconsultinggroup.com
571-447-5504