USA – FDA: New process for communicating record request issues

The US Food and Drug Administration (FDA) says it has put in place an interim process to communicate issues identified during record reviews done in lieu of or in advance of preapproval inspections with drugmakers and consider their responses before taking action on an application.

The agency says the interim process will continue throughout the COVID-19 public health emergency and may be extended to other drug inspection programs, including routine surveillance inspections.

Typically, FDA conducts a preapproval or prelicensure inspection before approving new drugs and biologics to ensure the facilities are operating in compliance with current good manufacturing practice (cGMP). However, due to the COVID-19 pandemic, FDA postponed most domestic and foreign surveillance inspections and has been relying on alternative tools such as records requests, where possible, to conduct facility assessments. (RELATED: FDA issues pandemic inspections FAQ guidanceRegulatory Focus 19 August 2020; Inspections: GAO calls on FDA to plan for backlog, review alternativesRegulatory Focus 1 February 2021)…