Drugs

FDA Discouraging ‘Sanitation Tunnels’

FDA has published an immediately-in-effect guidance, Covid-19 Public Health Emergency: Policy on Covid-19 Related Sanitation Tunnels, to discourage sponsors from developing or seeking approval or authorization for the use of sanitation tunnels. The document says sanitation tunnels are tunnels, walkways, chambers, and similar systems that spray humans with a mist of disinfectant or aerosolized antiseptic to prevent or treat Covid-19.

“At this time, there is a lack of data to demonstrate that sanitation tunnels are effective in reducing the spread of SARS-CoV-2 infection or in treating Covid-19,” FDA says. “Additionally, chemicals used in sanitation tunnels can irritate the skin, eyes, or airways and cause other health issues.”

The agency says such tunnels were first installed in China and have been developed in other countries outside the U.S. They generally are located outside crowded places such as food markets, shopping malls, hospitals, police stations, airports and train stations, offices, and industrial complexes, FDA says.

The guidance says there is no evident basis under the Federal Food, Drug, and Cosmetic Act under which sanitation tunnels can be legally marketed without an approved application. Sponsors interested in pursuing the development of such tunnels should submit a pre-investigational new drug application meeting request for Covid-19 drug development, it says.

“In a meeting package,” FDA says, “sponsors should address the concerns outlined in the guidance and how the proposed study design will ensure that human subjects are not exposed to an unreasonable and significant risk of illness or injury.

The guidance will be effective only during the duration of the declared Covid-19 public health emergency.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome