provides information on current regulations FDAAA 801 Requirements Which Trials Must be Registered Clinical Trial Registration Requirements (FDAAA 801) Responsible Party Food and Drug Administration Amendments Act of 2007 Food and Drug Administration Amendments Act (FDAAA) of 2007 certification (see note) Timelines 2007 Food and Drug Administration Amendments Act FDAAA 801 Requirements clinical trial reporting laws ClinicalTrials.gov FDAAA Section 801 FDAAA801 applicable clinical trials FDA Final Rule https://www.clinicaltrials.gov/ct2/manage-recs/fdaaa new rules from the National Institutes of Health FDAAA 801 and the Final Rule - ClinicalTrials.gov FDAAA 801 FDA Amendments Act https://clinicaltrials.gov/ct2/manage-recs/fdaaa require such publication (FDAAA 801) ClinicalTrials.gov Regulations Implementing FDAAA 801 FDAAA 801 FDA Amendments Act pediatric post-market surveillance Applicable clinical trials FDAAA 801 Clinical Trial Registration Requirements (FDAAA 801) expanded its requirements expanded its requirements there are penalties 12 months https://clinicaltrials.gov/ct2/manage-recs/fdaaa there are penalties FDA defines an Applicable Clinical Trial (ACT) mandated PRS and U.S. Public Law 110-85 new rules from the National Institutes of Health Section 801 of the Act Clinical Trial Registration Requirements (FDAAA 801) FDA defines an Applicable Clinical Trial (ACT) against the law Results Posting new rules from the National Institutes of Health ici apply to Bestimmungen Penalties for Failure to Submit compliance with FDAAA FDAAA 801 Requirements required by FDAAA in 2008 (FDAAA 801) FDAAA 801 ClinicalTrials.gov Requirements FDAAA 801 Requirements Section 801 penalties FDAAA 801 FDAAA 801 Requirements FDAAA required Other FDAAA 801 Requirements: NIH and FDA prescribed by FDAAA FDA Amendments Act When do I need to register and submit results? ClinicalTrials.gov Requirements FDAAA disclosure requirements “Applicable Clinical Trial”* FDAAA Section 80 https://clinicaltrials.gov/ct2/manage-recs/fdaaa definition Regulations Implementing FDAAA 801 http://clinicaltrials.gov/ct2/manage-recs/fdaaa Exclusions FDA FDA Amendments Act 801 Applicable Clinical Trial ClinicalTrials.gov Protocol Registration System ClinicalTrials.gov – FDAAA 801 Requirements https://clinicaltrials.gov/ct2/manage-recs/fdaaa final rule guide new rules from the National Institutes of Health Clinical Trial Registration Requirements (FDAAA 801) ClinicalTrials.gov must register their clinical trials on this site FDA