On April 7, 2020, FDA released a Q&A on manufacturing and supply change requests related to COVID-19 and drug shortages. In this Q&A, FDA provided the following guidance:
- Manufacturing site changes because of supply chain disruptions related to COVID-19 – If the site change is for treatment of patients with COVID-19 or for drugs on the shortage list, the cover letter of the submission should be labeled “Priority Review Requested” and include supporting information for the request. All other requests should be submitted normally.
- Supporting Data – Unless there are special circumstances resulting from the pandemic that would require atypical or flexible submission strategies, the relevant guidances should be followed.
- Filing applications in for facilities in regions impacted by COVID-19 travel-related restrictions – Applications can be filed if the facility is in a region impacted by travel restrictions.
- Will applications with sites that cannot be inspected due to travel restrictions automatically receive a Complete Response? – FDA stated that during the interim period, they are using additional tools to determine the need for an on-site inspection. Some of the tools that FDA may use are 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. If a determination is made that an on-site inspection is needed, then an application may receive a Complete Response.
FDA also provided contact information for additional questions – CDER-OPQ-Inquiries@fda.hhs.gov. FDA requested that companies include “COVID-19 inquiry” in the subject line of the email.
