US Profile Updated in ClinRegs

The United States profile in ClinRegs has been reviewed to ensure all information is up to date. Links to two recently released FDA guidelines have been added:

• The Guidance for Industry: Adaptive Designs for Clinical Trials of Drugs and Biologics, a new guide providing information for sponsors and applicants on the use of adaptive designs for clinical trials (See the Scope of Assessment, Submission Content, and Trial Authorization sections)
• The eCTD Technical Conformance Guide, which provides specifications on how to submit electronic Common Technical Document (eCTD)-based submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) (See the Submission Process section)