Charg­ing for ex­pand­ed ac­cess drugs: FDA to let com­pa­nies re­coup their costs over time

The FDA on Mon­day up­dat­ed guid­ance from 2016 on how com­pa­nies can charge for in­ves­ti­ga­tion­al drugs un­der an IND, now telling spon­sors work­ing un­der ex­pand­ed ac­cess that they can spread out their man­u­fac­tur­ing, ad­min­is­tra­tive or mon­i­tor­ing costs from the first year over the ex­pect­ed du­ra­tion of the ex­pand­ed IND or pro­to­col.

The shift may ease the im­me­di­ate cost bur­den for some small­er spon­sors that have ex­pen­sive bills to re­coup.

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