What Does The US Food And Drug Administration Do?

The Food and Drug Administration is

responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products

, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

What is the job of the Food and Drug Administration and the United States Department of Agriculture?

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 nation’s food supply, cosmetics, and products that emit radiation.

What does the US Food and Drug Administration currently regulate?

The FDA

regulates a wide range of products

, including foods (except for aspects of some meat, poultry and egg products, which are regulated by the U.S. Department of Agriculture); human and veterinary drugs; vaccines and other biological products; medical devices intended for human use; radiation-emitting electronic …

What are grandfathered drugs?

Drugs that were already on the market were

“grandfathered” and allowed to remain on the market without further regulatory approval if they were labeled with the same conditions of use. Many of these products remain on the market today.

What products do not need FDA approval?

Examples of cosmetics are

perfumes, makeup, moisturizers, shampoos

, hair dyes, face and body cleansers, and shaving preparations. Cosmetic products and ingredients, and their labeling, do not require FDA approval before they go on the market. There’s one exception: color additives (other than coal-tar hair dyes).

How important is FDA approval?

FDA approval is important, because it

validates the need for research on how drugs work on children

, not just adults. It also allows us the properly determine the appropriate dosage for children, determine the best route of administration, and test for any drug interactions.

How long does FDA approval take for food?

A standard review means that the FDA can take

as long as 12 months after the NDA is submitted

to review the data and grant approval. With a priority review, the FDA calls on a larger number of staff to review the NDA, reducing the approval time to less than six months.

Who really controls the FDA?

The FDA is led by

the Commissioner of Food and Drugs

, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services.

Do drugs have to be FDA approved?

FDA Approval is Required by Law

Federal law requires all new drugs in the U.S. be shown to be safe and effective for their intended use prior to marketing. However, some drugs are available in the U.S. even though they have never received the required FDA approval.

How do drugs get FDA approved?

FDA Drug-Approval Process. A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process:

discovery/concept, preclinical research, clinical research, FDA review and FDA post-market safety monitoring

.

Can doctors prescribe unapproved drugs?

Off-label drug use is when

doctors legally prescribe drugs for unapproved uses

. The FDA has no control over how doctors prescribe drugs. Off-label drug use is not without risks.

When is FDA approval needed?

If a new drug does not comply with a monograph

, it will require FDA approval. To get FDA approval, drug manufacturers must conduct lab, animal, and human clinical testing and submit their data to FDA.

Does Toothpaste need FDA approval?

Although the U.S. Food and Drug Administration monograph

²⁷

stipulates that manufacturers of fluoride-containing toothpaste meet certain requirements for the product’s active ingredients, product indications, claims and other qualifications,

the FDA does not test toothpastes to verify compliance

.

What products must be FDA approved?

• Human and animal drugs.
• Medical biologics.
• Medical devices.
• Food (including animal food)
• Tobacco products.
• Cosmetics.
• Electronic products that emit radiation.

Does FDA approval mean anything?

The approval, says the FDA, means “

the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product

.”

What are the 4 phases of FDA approval?

• Phase I: Discovery & Development.
• Phase II: Preclinical Research.
• Phase III: Clinical Research.
• Phase IV: FDA Review.
• Phase V: FDA Post-Market Safety Monitoring.