FDA Submissions Now More Consistent

Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions using the eCTD Specifications Status: Final Date: October 2005 Organizations: United States Department of Health and Human Services, Food and Drug...

How to Accept Foreign Clinical Trial Data

Acceptance of Foreign Clinical Trial Data Status: Final Date: June 1998 Organizations: Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH) Target Audience: Clinical...

Waiver of IRB Requirements for IECs Outside the US

Information Sheet Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards (IRBs). Waiver of IRB Requirements for Drug and Biological Products Studies. Status: Final Date: January 2006 Organization: United States Food and Drug Administration...