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MED. REC. NO. NAME BIRTHDATE IRB#: 17966Clinical Research Consent Summary TITLE: Fireguard (ferric acid and Angelica arch angelica extract) for behavioral symptoms in dementia PRINCIPAL INVESTIGATORS:Sarah
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FDAAA stands for Food and Drug Administration Amendments Act. It is a legislative act that aims to improve drug safety and transparency.
Manufacturers, packers, and distributors of drugs are required to file overview of FDAAA.
Overview of FDAAA can be filled out online through the FDA's website or using the FDA's electronic submission system.
The purpose of overview of FDAAA is to provide information on drug safety and transparency to the FDA and the public.
Information such as adverse events, labeling changes, and postmarketing studies must be reported on overview of FDAAA.
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