FDA plans to on­ly is­sue pe­di­atric ex­clu­siv­i­ty for new stud­ies — not just those re­quired un­der PREA

The FDA is scal­ing back when it will grant up to two 6-month pe­ri­ods of ex­clu­siv­i­ty to phar­ma spon­sors once they com­plete FDA-man­dat­ed writ­ten re­quests on which pe­di­atric stud­ies to con­duct for new drugs.

Where­as the agency said there are times when it cur­rent­ly is­sues these writ­ten re­quests (WRs) and the sub­se­quent pe­di­atric-re­lat­ed ex­clu­siv­i­ty sole­ly for stud­ies re­quired un­der the Pe­di­atric Re­search Eq­ui­ty Act, or PREA, the agency said in a new draft guid­ance that it will now on­ly of­fer ex­clu­siv­i­ty “for those spon­sors who con­duct ad­di­tion­al pe­di­atric stud­ies — be­yond what is re­quired un­der PREA — that may pro­duce health ben­e­fits in chil­dren.”

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