US regulators defend requiring more data on monkeypox drug - SABC News - Breaking news, special reports, world, business, sport coverage of all South African current events. Africa's news leader.

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The FDA approved TPOXX in 2018 for smallpox in adults and children based on studies of animals infected with monkeypox and rabbitpox, as well as safety data in healthy people. It can only be sold to the US Strategic National Stockpile. Although TPOXX was only tested in healthy people, the European Medicines Agency said it expects side effects to be similar in infected people, and deemed the drug’s benefits to be greater than its risks.

On July 21, the CDC and the FDA began allowing doctors to prescribe the drug before the trial paperwork is completed, but still requires approval of a hospital’s institutional review board for each dose.

Just watch SAns queue up to take TPOXX how crazy is that

Andizi

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Fonte: allafrica - 🏆 1. / 99 Consulte Mais informação »