Re­al world da­ta and FDA: Drug­mak­ers seek more clar­i­ty on reg­istry guid­ance

As the FDA crafts a new se­ries of guid­ance doc­u­ments on how bio­phar­ma com­pa­nies can use re­al-world da­ta, in­clud­ing pa­tient reg­istries, to help sup­ple­ment their ap­pli­ca­tions, phar­ma com­pa­nies and in­dus­try group PhRMA are call­ing for more de­tails and more con­sis­ten­cy from the agency.

The push from in­dus­try around the use of re­al-world da­ta has been sup­port­ed by both the 21st Cen­tu­ry Cures Act and in­dus­try-ne­go­ti­at­ed PDU­FA VI (the next it­er­a­tion of which is com­ing soon).

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