In this week’s news, the FDA is pressured to address Covid-19 inspection backlogs, The WHO sets out manufacturing safety measures around radiopharmaceuticals and CDMOs are urged to start planning for post-COVID demands.
GAO says US FDA needs to address Covid-19 inspection backlog and overseas inspection
The US Government Accountability Office has raised concerns about the FDA’s facility inspection backlog.
The GAO made the comments in a report published late last week, writing that the agency need to put together a plan to deal with the backlog and address longstanding issues related to overseas inspections.
“The outbreak of COVID-19 has called greater attention to the United States’ reliance on foreign drug manufacturers. FDA reports that 74 percent of establishments manufacturing active ingredients and 54 percent of establishments manufacturing finished drugs for the U.S. market were located overseas, as of May 2020.
“GAO has had long-standing concerns about FDA’s ability to oversee the increasingly global pharmaceutical supply chain.”
WHO and IAEA advise on radiopharmaceuticals production
The WHO has set out the manufacturing safety measures CDMOs and drug firms making radiopharmaceutical should use.
The WHO – in collaboration with the International Atomic Energy Agency (IAEA) – issued draft GMP guidelines for investigational radiopharmaceuticals this week, citing the growing number of such products entering development.
The organisation wrote “Radiopharmaceuticals are rapidly re-emerging as clinically valuable tools used in the diagnosis and treatment of various types of disease,” adding “This rapid expansion is accompanied by a set of challenges due to the complexity and unique nature of these agents.”
The WHO cited manufacturing control as one of the major challenges, pointing out that measures used during production for early studies need to be augmented for later Phase trials.
The guidance provides a recommended quality management system and details which personnel should be involved with which aspects of production and development as well as the clinical trial process.