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What is the FDA mission statement?

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nations food supply, cosmetics, and products that emit radiation.

What happens if you dont follow FDA guidelines?

Debarment Disqualification For certain serious violations of the FDC Act, FDA may debar or disqualify an individual or company. Debarment and disqualification prohibit the person or organization from engaging in the type of activity in which the violation occurred.

How do I know if my product is FDA approved?

Most FDA-approved human drugs and therapeutic biological products are listed in Drugs @ FDA, a searchable database. The database allows you to search by drug name, active ingredient, or application (NDA, ANDA, or BLA) number. Look up the drug in the Orange Book or the biological product in the Purple Book.

Is it bad if its not FDA approved?

Unapproved prescription drugs pose docHub risks to patients because they have not been reviewed by FDA for safety, effectiveness or quality.

What are the examples of FDA violations?

A company fails to register and list their medical device products with the FDA, preventing the FDA from having required information about a device on the market. A manufacturer knowingly deceives the FDA. For example, the manufacturer hides information from the FDA, or falsifies documents, etc.

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Are FDA guidelines legally binding?

Guidance documents are issued to provide a little bit more information about what people can do to comply with existing requirements. They represent FDAs current thinking on matters, but they are not binding, so industry could also do things in a different way, as long as they comply with the statutes and regulations.

Is FDA guidance mandatory?

FDAs guidance documents, including this guidance, do not establish legally enforceable responsibilities.

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