Next-gen mpox treat­ments: FDA calls for di­verse, ran­dom­ized con­trolled tri­als

For com­pa­nies look­ing to de­vel­op the next mpox (for­mer­ly known as mon­key­pox) an­tivi­rals, the FDA came out with new draft guid­ance yes­ter­day spelling out the de­tails of what such de­vel­op­ment pro­grams should in­clude.

One of the ma­jor points in the draft is the FDA is call­ing for any new mpox treat­ments to run ran­dom­ized con­trolled tri­als with wide racial and eth­nic di­ver­si­ty and those with HIV, as mpox dis­pro­por­tion­ate­ly af­fects these pop­u­la­tions.

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