Risk-ben­e­fit de­ter­mi­na­tions: FDA fi­nal­izes long-await­ed guid­ance for drug­mak­ers

The FDA on Thurs­day fi­nal­ized guid­ance from Sep­tem­ber 2021 on the agency’s ben­e­fit-risk as­sess­ments for new drugs and bi­o­log­ics, spelling out its most per­ti­nent con­sid­er­a­tions …

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