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FDA Declines Approval of ViiV’s Injectable HIV Regimen Cabenuva
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Well, if the drugs remain in the system for weeks after the stopping of the treatment, then of course there is a big issue. Hence, it's correct for the FDA to refuse a license. But perhaps those who really want it can sign a waiver - and have to pass a multiple choice quiz to show that they fully understand the risks...
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Johnny Boon
@RichardUK why would that be an issue when there long lasting drugs on the market already and that is not a safety issue. Patients signing waivers would not get around a safety concern of the FDA. It's why clinical trials are required. Their rejection has nothing to do with patient saftey.
December 27, 2019 • Alabama