FDA Plans To Improve COVID-19 EUA Process, Inspection Work Based On Report Recommendation
The agency is taking to heart several recommendations made by an independent reviewer earlier this year in a report on its COVID-19 response.
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FDA Presses Domestic Manufacturers To Engage In Remote Regulatory Assessments In Lieu Of Inspections
A US FDA official says the agency’s taking steps to plan for post-pandemic on-site inspections that could look slightly different than typical agency audits pre-COVID-19. But in the interim, some companies are being asked to participate in voluntary Remote Regulatory Assessments.
Acting FDA Commissioner Janet Woodcock says FDA is interested in establishing new ‘Centers of Excellence’ but the current environment is not the right time to make changes at the agency. Woodcock also talked about where FDA will spend its new pandemic money and its reexamination of accelerated approval drugs in a wide-sweeping conversation with the Alliance for a Stronger FDA.
The US agency has pulled the emergency use authorization for Battelle’s face mask decontamination system after a request from the company, which has also closed sites where masks were being decontaminated.