Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top bio­phar­ma com­pa­nies are seek­ing more de­tails from the FDA on how the agency con­ducts its ben­e­fit-risk as­sess­ments for new drugs and bi­o­log­ics.

While Pfiz­er, Am­gen and Janssen praised the agency for fur­ther spelling out its think­ing on the sub­ject in a new draft guid­ance, in­clud­ing a dis­cus­sion of pa­tient ex­pe­ri­ence da­ta as part of the as­sess­ment, the com­pa­nies said the FDA could’ve in­clud­ed more specifics in the 20-page draft doc­u­ment.

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