Os­teoarthri­tis: FDA drafts guid­ance on de­vel­op­ing drugs, de­vices, bi­o­log­ics

The FDA on Wednes­day pub­lished draft guid­ance to help drug, de­vice and bi­o­log­ic spon­sors de­vel­op prod­ucts to treat the un­der­ly­ing patho­phys­i­ol­o­gy and struc­tur­al pro­gres­sion of os­teoarthri­tis (OA).

The three-page draft fea­tures back­ground in­for­ma­tion on how the agency has re­lied on pa­tient-re­port­ed out­comes in ap­provals, as well as three bul­let­ed con­sid­er­a­tions for de­vel­op­ment.

“Ap­provals for OA to date have been based on pa­tient-re­port­ed out­come mea­sures that as­sess pain and func­tion. How­ev­er, treat­ments that in­hib­it struc­tur­al dam­age or tar­get the un­der­ly­ing patho­phys­i­ol­o­gy as­so­ci­at­ed with OA re­main elu­sive and rep­re­sent an un­met med­ical need,” the draft notes.

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