FDA Using Temporary Measure to Communicate Record Request Findings During Pandemic

The FDA is using a temporary process during the pandemic for communicating issues it finds after reviewing records or other information requested in lieu of or in advance of pre-approval or pre-license inspections for Center for Drug Evaluation and Research (CDER)-regulated products.

Under the agency’s temporary measure, the FDA will, as feasible, consider formal responses from facilities regarding issues it identifies before it takes action on a pending application. The agency has been working directly with facilities during the COVID-19 emergency to point out issues brought to light from record and information reviews.

“The agency encourages applicants to be in communication with all their facilities and sites to ensure timely responses to any inquiries to support application assessment,” the FDA said.

The new process is outlined in an updated version of the agency’s guidance on manufacturing, supply chain, and drug and biological product inspections during the health crisis.

With the pandemic creating travel and on-site inspections difficult for the FDA, the agency has opted to review records and other information from facilities when it can instead of conducting in-person inspections. It is also leveraging its mutual recognition agreements and confidentiality agreements with other regulators to obtain existing inspection reports when possible, among other measures.

“CDER and [the Center for Biologics Evaluation and Research] are continuing to evaluate applications, strategically applying a holistic approach in the decision-making process to determine if an inspection is warranted or if an inspection is no longer needed due to information gained through the use of [our additional tools],” the agency said.

Read the revised guidance here: www.fdanews.com/02-03-21-COVID19MfgInspecQA.pdf. — James Miessler