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Food and Drug Administration Amendments Act of 2007
Law whose section 801 made registration of certain trials, and posting of their results, at ClinicalTrials.gov a legal duty.
- Dates
- 27 Sep 2007
- Also known as
- FDAAA
- The Settlements20 scenes
- How are Food and Drug Administration Amendments Act of 2007 and … connected?
Connections 3
enacted by
-
U.S. Congress
27 Sep 2007
Primary record
1
The source says the statutory requirements have been in effect since this date.
led to
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Clinical trial registration
Primary record
1
Section 801 of the Act.
features
- ClinicalTrials.gov where covered trials must be registered and report results Primary record 1
Timeline 2 dates
- 27 Sep 2007 Food and Drug Administration Amendments Act of 2007
- 27 Sep 2007 U.S. Congress signed into law Food and Drug Administration Amendments Act of 2007
Proof 1 source
-
FDAAA 801 and the Final Rule (ClinicalTrials.gov; archived 8 Jan 2019), ClinicalTrials.gov, National Library of Medicine.
Primary record
The statutory requirements have been in effect since September 27, 2007, have been codified at section 402(j) of the Public Health Service (PHS) Act
The responsible party for an applicable clinical trial (ACT) must register the trial and submit results information.
Page history 1 change
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