FDA-EMA work­shop dis­cuss­es qual­i­ty chal­lenges for PRIME, break­through ther­a­pies

Last No­vem­ber, of­fi­cials from the EMA and FDA met with in­dus­try rep­re­sen­ta­tives in Lon­don to dis­cuss the var­i­ous qual­i­ty chal­lenges that arise when the de­vel­op­ment of in­ves­ti­ga­tion­al prod­ucts is ac­cel­er­at­ed.

The EMA’s launch of its pri­or­i­ty med­i­cines (PRIME) scheme and the FDA’s break­through ther­a­py des­ig­na­tion have en­abled com­pa­nies to speed cer­tain treat­ments to mar­ket, al­though there have been dif­fi­cul­ties in iden­ti­fy­ing pos­si­ble sci­en­tif­ic and reg­u­la­to­ry ap­proach­es to fa­cil­i­tate the type of ro­bust qual­i­ty da­ta pack­ages nec­es­sary to en­sure that pa­tient safe­ty and prod­uct qual­i­ty and ef­fi­ca­cy are not com­pro­mised, ac­cord­ing to a re­port re­leased Wednes­day on the work­shop.

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