JA­MA study shows phar­ma com­pa­nies strug­gle to meet postap­proval study dead­lines

When new drugs win ap­proval in the US, the FDA of­ten tasks spon­sors with con­duct­ing post­mar­ket stud­ies as a con­di­tion of the OKs, with dead­lines set and plans of­ten hashed out ahead of the ap­proval.

But a new JA­MA study shows that for the 135 new drugs ap­proved from 2013 to 2016, of all re­portable post­mar­ket com­mit­ments (PM­Cs) and post­mar­ket re­quire­ments (PMRs) is­sued at ap­proval (387 PMRs and 87 re­portable PM­Cs), 330 (70%) were ex­pect­ed to be com­plet­ed by Q4 2020, but 238 (72%) were late.

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