由 John R. Fischer
, Senior Reporter | March 20, 2020
The FDA has temporarily halted all domestic routine surveillance inspections of facilities in an effort to keep staff and agency inspectors safe during the coronavirus pandemic.
The move follows a similar action taken by the agency earlier this month to postpone most foreign facility inspections through April. It also is directing all eligible FDA employees to work from home via telecommunications.
“While this [teleworking] does not apply to those carrying out non-portable activities, such as certain lab activities or the monitoring of imported products, we will continue to adjust our approach to a number of activities, including facility inspections for all FDA-regulated products such as food, animal feed, drugs, biological products, devices and tobacco,” said the FDA in a statement.
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Facility inspections are conducted every few years based on a risk analysis. The agency will continue to conduct all domestic-for-cause inspection assignments and will take action if such cases are deemed mission critical. It also is considering inspections outside the U.S. that are deemed mission critical on a case-by-case basis.
“We believe FDA-regulated firms understand and appreciate their shared responsibility to ensure the integrity of the supply chain and we will continue to communicate with them during this time to underscore this partnership.”
Guidelines for the conduct of clinical trials during the pandemic have also been issued, including for medical devices, drugs and biological products. It warns that personnel or trial subjects that become infected with SARS-CoV-2 — the virus that causes COVID-19 — may create challenges for clinical trials, as could quarantines, site closures, travel limitations or interruptions in supply chains for the investigational product.
The FDA acknowledges that protocol modifications and unavoidable protocol deviations may be necessary, and makes the recommendation, among others, that sponsors of trials consider alternative methods for assessments, including phone contacts or virtual visits. It recommends that additional safety monitoring be put in place for trial participants who may no longer be able to access investigational products or investigational sites.
“The FDA released this guidance to emphasize that at all times, patients’ safety should continue to be at the forefront of considerations,” said the agency. “We want to support the continuance of these clinical trials in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants.”
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