ClinicalTrials.gov significant event Food and Drug Administration Amendments Act of 2007
Federally and privately funded clinical trials;
The purpose of each experimental drug;
Subject eligibility criteria to participate in the clinical trial;
The location of clinical trial sites being used for a study; and
A point of contact for patients interested in enrolling in the trial.The National Library of Medicine in the National Institutes of Health made ClinicalTrials.gov available to the public via the internet on February 29, 2000.  In this initial release, ClinicalTrials.gov primarily included information about NIH-sponsored trials, omitting the majority of clinical trials being performed by private industry.  On March 29, 2000 the FDA issued a Draft Guidance called Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank and put into In) with the hope that this would increase use by industry.  After a second draft guidance was released in June 2001, a final guidance was issued on March 18, 2002 titled "Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions".  The Best Pharmaceuticals for Children Act of 2004 (Public Law 107-109) amended the Public Health Service Act to require that additional information be included in ClinicalTrials.gov.
As the result of toxicity tracking concerns raised following retraction of several drugs from the prescription market, ClinicalTrials.gov was further reinforced by the Food and Drug Administration Amendments Act of 2007 (U.S. Public Law 110-85) which mandated the expansion of ClinicalTrials.gov for better tracking of the basic results of clinical trials, requiring:
Data elements that facilitate disclosure, as required by the FDAAA, as well as operations of ClinicalTrials.gov; and
"Basic results" reporting.Timeline
November 21, 1997	The Food and Drug Administration Modernization Act of 1997 mandates a clinical trials registry
February 29, 2000	ClinicalTrials.gov comes online
September 16, 2004	ICMJE recommendations mandate that research journals exclude outcomes from non-registered trials
September 27, 2007	Food and Drug Administration Amendments Act of 2007 section 801 mandates registration and penalty for noncompliance
September 27, 2008	reporting results is mandatory
September 27, 2009	reporting adverse events is mandatory