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PREMARKET TOBACCO PRODUCT APPLICATION CONTENT Over-represented By: Milan Murphy, MD Director Division of Individual Health Science Office of Science, CTP, Disclaimer: This is not a formal dissemination
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US Food and Drug Administration (FDA) is a federal agency responsible for protecting and promoting public health through the regulation and supervision of food safety, dietary supplements, prescription and over-the-counter medications, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods & feed and veterinary products.
Manufacturers, distributors, importers, packers, and other entities involved in the production and distribution of food, drugs, medical devices, or other FDA-regulated products may be required to file with the FDA.
To fill out FDA registration forms, businesses must create an account on the FDA Unified Registration and Listing System (FURLS) and provide detailed information about their products, facility, and compliance with FDA regulations.
The purpose of the FDA is to protect and promote public health by ensuring the safety, efficacy, and security of human and veterinary drugs, vaccines, medical devices, food supply, cosmetics, and products that emit radiation.
Information such as product details, manufacturing processes, facility information, ingredient lists, labeling, and compliance with FDA regulations must be reported on FDA registration and listing forms.
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