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 in de­ter­min­ing whether a new ap­pli­ca­tion’s ben­e­fits out­weigh the risks.

The 23-page guid­ance, cre­at­ed as part of FDA’s 21st Cen­tu­ry Cures Act com­mit­ments, of­fers high-lev­el thoughts on how a drug’s ben­e­fits, risks, and risk man­age­ment fac­tor in­to FDA’s pre- and post-mar­ket reg­u­la­to­ry de­ci­sions.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.