Posted 24 August 2017
By Michael Mezher
The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA) will soon launch an effort to streamline the two offices' inspection and facility evaluation efforts.
In an email to FDA staff on Monday, CDER Director Janet Woodcock and Associate Commissioner for Regulatory Affairs Melinda Plaisier said it is vital that the two offices quickly implement the plan in order to meet commitments under the recently reauthorized user fee agreements, specifically citing the agency's promise to communicate final inspection classifications to generic drugmakers within 90 days of an inspection beginning in October 2018.
"We plan to operationalize the plan in the fall of 2017 for nearly all human drugs," Woodcock and Plaisier added.
FDA details the plan—which includes specific operating models for pre- and post-approval inspections, surveillance inspections and for-cause inspections—in a 20-page white paper obtained by Focus entitled Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations (ConOps).
For each type of inspection, FDA provides a model for planning and conducting the inspection, as well as the process for communicating inspection findings both within FDA and to the sponsor.
The document also includes decision trees detailing the workflow for each type of inspection and RACI (responsibility, accountability, consulted and informed) charts that clarify which office is responsible or accountable for the various tasks involved.