FDA+ roundup: FDA continues to loosen standard of evidence for novel drug approvals — JAMA research letter

The FDA is con­tin­u­ing to low­er the bar of its ap­proval stan­dards for nov­el drug ap­pli­ca­tions, ac­cord­ing to a new analy­sis of ev­i­dence on ap­provals in 2022.

In a re­search let­ter pub­lished Tues­day in JA­MA, au­thors Robert Ka­plan, Aman­da Koong and Veron­i­ca Irvin eval­u­at­ed the ev­i­dence sup­port­ing FDA’s 37 new drug ap­provals in 2022, and what they found sug­gests that the agency has con­tin­ued to use a less rig­or­ous stan­dard for ap­proval of nov­el drugs over the past sev­er­al years.

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.