WebSection 801 of the Food and Drug Administration Amendments Act (FDAAA 801) (PDF) requires responsible parties to register clinical trials and submit summary results to ClinicalTrials.gov. The law applies to certain clinical trials of drug, biological, and device products and has been in effect since September 27, 2007. Web§ 11.2 What is the purpose of this part? This part implements section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)) by providing requirements and procedures for the …
Enforcing Compliance to FDAAA 801 Clinical Trial …
Webapplicable device clinical trial. The trial would generally be considered an applicable drug clinical trial. Review the following criteria to determine if the applicable clinical trial … WebMay 15, 2024 · In general, FDAAA 801 also mandates registration and reporting of summary results of clinical trials of medicines and devices subject to FDA regulation on the freely-accessible site ClinicalTrials.gov, no later than 12 months after the Completion Date. downloadable example of barber shop invoice
ClinicalTrials.gov and CTRP - DF/HCC
WebFDAAA 801 and the Final Rule; Wherewith to Applying for a PRS Account; How to Register Your Study; How to Edit Your Study Record; How on Submit Our Results; Frequently Requested Questions; Support Materials; Training Materials; Resources. Selektierte Publications; Clinical Alerts and Advisories; RSS Feeds; Trending, Designs, and Maps WebMar 7, 2024 · HHS issued a final rule, which is codified at 42 CFR Part 11, as required by Title VIII of FDAAA, to clarify and expand the requirements for registering clinical trials … WebJun 27, 2024 · The final rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) specifies requirements for submitting clinical trial … downloadable eviction template