FDA commissioner Rob Califf (AP Photo/Jose Luis Magana)

Gov­ern­ment-paid ex­perts help­ing in­dus­try at the ta­ble with FDA? Agency spells out guardrails

The FDA-bio­phar­ma in­dus­try re­volv­ing door can some­times spin so fast that it’s dif­fi­cult to keep up with who’s rep­re­sent­ing what in­ter­ests.

While the FDA’s re­views of new drugs are en­tire­ly fund­ed by in­dus­try, the agency is fa­mous­ly the on­ly drug reg­u­la­tor in the world that ac­tu­al­ly per­forms its own analy­ses of the raw da­ta gen­er­at­ed by new bio­phar­ma spon­sor tri­als, and has al­ways tak­en its ob­jec­tiv­i­ty se­ri­ous­ly.

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