http://clinicaltrials.gov/ct2/manage-recs/fdaaa US law Public Law 110-85, Title VIII PRS and U.S. Public Law 110-85 http://clinicaltrials.gov/ct2/manage-recs/fdaaa see Public Law 110-85, Title VIII FDAAA 801 Requirements source PRS and U.S. Public Law 110-85 http://clinicaltrials.gov/ct2/manage-recs/fdaaa typically lasting around a month ClinicalTrials.gov Protocol Registration System ClinicalTrials.gov Protocol Registration System http://www.clinicaltrials.gov/ct2/manage-recs/fdaaa law http://clinicaltrials.gov/ct2/manage-recs/fdaaa Delayed Submission of Results http://clinicaltrials.gov/ct2/manage-recs/fdaaa http://clinicaltrials.gov/ct2/manage-recs/fdaaa provide a citation to a page U.S. Public Law 110-85 Information Page mandatory reporting strictures FDAAA 801 Requirements U.S. Public Law 110-85 Information Page typically lasting around a month U.S. Public Law 110-85 Clinical Trials of Devices http://clinicaltrials.gov/ct2/manage-recs/fdaaa http://www.clinicaltrials.gov/ct2/manage-recs/fdaaa http://clinicaltrials.gov/ct2/manage-recs/fdaaa Food and Drug Administration Amendments Act of 2007 (FDAAA) http://clinicaltrials.gov/ct2/manage-recs/fdaaa see Public Law 110-85, Title VIII see Public Law 110-85, Title VIII Delayed Submission of Results http://clinicaltrials.gov/ct2/manage-recs/fdaaa http://clinicaltrials.gov/ct2/manage-recs/fdaaa applicable clinical trials FDAAA 801 Requirements http://clinicaltrials.gov/ct2/manage-recs/fdaaa PRS and U.S. Public Law 110-85 http://www.clinicaltrials.gov/ct2/manage-recs/fdaaa http://clinicaltrials.gov/ct2/manage-recs/fdaaa ClinicalTrials.gov Protocol Registration System Public Law 110-85, Title VIII http://www.clinicaltrials.gov/ct2/manage-recs/fdaaa ClinicalTrials.gov Reporting Requirements http://clinicaltrials.gov/ct2/manage-recs/fdaaa U.S. Public Law 110-85 Information Page law http://clinicaltrials.gov/ct2/manage-recs/fdaaa http://clinicaltrials.gov/ct2/manage-recs/fdaaa PRS and U.S. Public Law 110-85 Clinical Trials of Drugs and Biologics http://clinicaltrials.gov/ct2/manage-recs/fdaaa ClinicalTrials.gov Protocol Registration System FDAAA 801 Requirements see Public Law 110-85, Title VIII http://clinicaltrials.gov/ct2/manage-recs/fdaaa US law Public Law 110-85, Title VIII U.S. Public Law 110-85 Information Page US law Public Law 110-85, Title VIII webpage aren’t legally required http://clinicaltrials.gov/ct2/manage-recs/fdaaa US law Public Law 110-85, Title VIII http://clinicaltrials.gov/ct2/manage-recs/fdaaa FDAAA 801 Requirements http://clinicaltrials.gov/ct2/manage-recs/fdaaa http://clinicaltrials.gov/ct2/manage-recs/fdaaa http://clinicaltrials.gov/ct2/manage-recs/fdaaa http://clinicaltrials.gov/ct2/manage-recs/fdaaa FDAAA 801 Requirements FDAAA applicable clinical trials typically lasting around a month http://clinicaltrials.gov/ct2/manage-recs/fdaaa ClinicalTrials.gov Reporting Requirements Public Law 110-85, Title VIII pediatric postmarket surveillance http://clinicaltrials.gov/ct2/manage-recs/fdaaa http://clinicaltrials.gov/ct2/manage-recs/fdaaa http://clinicaltrials.gov/ct2/manage-recs/fdaaa Title VIII-Section 801 http://clinicaltrials.gov/ct2/manage-recs/fdaaa http://clinicaltrials.gov/ct2/manage-recs/fdaaa ClinicalTrials.gov Protocol Registration System Title VIII-Section 801 http://www.clinicaltrials.gov/ct2/manage-recs/fdaaa http://www.clinicaltrials.gov/ct2/manage-recs/fdaaa