Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) amended the Public Health Service Act (PHS Act) by adding section 402(j) (42 U.S.C. 282(j)). The new provisions require additional information to be submitted to the clinical trials data bank (ClinicalTrials.gov), including expanded information on clinical trials and information on the results of clinical trials.

One new FDAAA provision, 42 U.S.C. 282(j)(5)(B), requires that a certification (see form below) accompany human drug, biological, and device product submissions made to FDA. At the time of submission of an application under sections 505, 515, or 520(m) of the FD&C Act (21 U.S.C. 355, 360e, or 360j(m)), or under section 351 of the PHS Act (21 U.S.C. 262), or submission of a report under section 510(k) of the FD&C Act (21 U.S.C. 360(k)), such application or submission must be accompanied by a certification that all applicable requirements of section 402(j) of the PHS Act have been met. Where available, such certification must include the appropriate ClinicalTrials.gov identifiers (NCT numbers).

Additional information from the FDA:

Historic References

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