FDA finalizes guidance on adaptive trial designs
The FDA last week finalized guidance on adaptive clinical trial designs for drugs and biologics.
The 33-page guidance, which finalizes a draft version released for comment in September 2018 and replaces an earlier guidance from 2010, sets out the FDA’s recommendations on adaptive trial design principles and the information the FDA will review from adaptive studies submitted as part of investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs) and supplemental applications.
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.