Section 801 Clinical Trial

Public law 110 85 title viii section 801.

Section 801 clinical trial. Fdaaa 801 establishes penalties for responsible parties who fail to comply. September 19 2016 clinical trials data sharing research reporting standards clinicaltrials gov data reporting fdaaa final rule section 801 jonathan mccall. If this study includes an fda regulated intervention indicate whether this is an applicable clinical trial as defined in u s.

Fdaaa section 801 and the final rule 42 cfr part 11 section 801 of the food and drug administration amendments act fdaaa 801 refers to a federal statute established in 2007 requiring the registration and reporting of information on applicable clinical trials on clinicaltrials gov. Final rule for section 801 of the food and drug administration amendments act of 2007 42 cfr part 11 final rule webinar series 1 of 3 september 27 2016. These penalties include civil monetary penalties up to.

This page summarizes the clinical trial registration and results information submission requirements described in section 801 of the food and drug administration amendments act of 2007 pdf known as fdaaa 801. Section 801 of the food and drug administration amendments act fdaaa 801 requires responsible parties to register and submit study results of clinical trials with clinicaltrials gov. Importation of certain fda approved human prescription drugs including biological products under section 801 d 1 b of the federal food drug and cosmetic act.

In 2016 the department of health and human services hhs issued a regulation to further increase the availability of information about clinical trials and clarify fdaaa 801. A service of the u s. Fdaaa certification to accompany drug biological product and device applications or submissions the recently enacted u s.

Public law 110 85 food and drug administration amendments act of 2007. National institutes of health. As lane explained section 801 of the fda amendments act fdaaa of 2007 is the baseline regulation defining clinical trial disclosure in the us.

The regulation was refined in 2016 with the issuance of 42 cfr part 11 for clinical trials registration and results information submission commonly referred to as the final rule. Section 801 clinical trial definition. On friday of last week the us department of health and human services published a long awaited final rule pdf that governs the registration and data reporting for clinical trials with clinicaltrials gov.