What is section 801?
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.
What is the title of 21 USC 801?
Food and Drugs
§ 801 – U.S. Code – Unannotated Title 21. Food and Drugs § 801. Congressional findings and declarations: controlled substances.
What is 21 usc 801 et seq?
21 U.S. Code § 801 – Congressional findings and declarations: controlled substances. Many of the drugs included within this subchapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people.
What is FDA final rule?
The final rule addresses the statutory requirement for the submission of summary results information for applicable clinical trials of drug products (including biological products) and device products that are approved, licensed, or cleared by FDA.
Do all clinical trials have to be registered?
The International committee of medical journal editors requires registration of trial methodology, but does not require registration of trial results; however, the U.S. Food and Drug Administration Amendments does require researchers to register results.
What is a Schedule 1 drug?
Schedule I Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse. Some examples of Schedule I drugs are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote.
Who is responsible for clinical trial?
Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals.
What is the final rule for clinical trials?
The final rule considers all clinical trials with one or more arms and with one or more pre-specified outcome measures to be controlled clinical trials. The final rule explains that we have determined that no expanded access use would be considered an applicable clinical trial under section 402(j) of the PHS Act.
What is NCT number?
National Clinical Trial number
NCT Number: The National Clinical Trial number is an identification that ClinicalTrials.gov assigns a study when it is registered. The NCT number is in the format “NCTXXXXXXXX”. Until an NCT number is assigned, the study is not registered.
