6-8 October 2021
In a letter sent directly to Janet Woodcock, Acting Commissioner, US Food and Drug Administration (FDA), the Congress of the United States, House of Representatives (Committee on Energy and Commerce) expresses its concerns about a backlog of pharmaceutical manufacturing facility inspections and human drug applications.
For the authors, "the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear". Furthermore, it is not clear how delayed inspections will impact drug applications and approvals.
Given these concerns, the authors ask some inspection related questions and expect responses within a timeframe of two weeks. These questions also attempt to collect concrete data that has not yet been published. These include for example:
Overall the authors want to know how long it will take, "after a return to standard operations for both domestic and foreign inspections, to resolve the inspections backlog caused by the pause in inspections during the COVID-19 pandemic?"