FDA proposes framework clinical trial designs to guide Bayesian methods, improving efficiency in drug development for rare and pediatric conditions.

The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...

The U.S. Food and Drug Administration (FDA) issued this week three guidance documents related to clinical trials: a draft guidance on multiregional trials in oncology, a draft guidance on integrating ...

The Food and Drug Administration (FDA) has issued a new guidance document entitled “Enhancing Participation in Clinical Trials – Eligibility Criteria, Enrollment Practices, and Trial Decision.” The ...

The FDA’s Center for Devices and Radiological Health has withdrawn its December 2017 final guidance for clinical evaluation ...

To help clinical trial sponsors who are planning global cancer studies best position themselves for FDA approval, the agency has released draft guidance for conducting multiregional clinical trials in ...