Center for Drug Evaluation and Research (CDER)

Question 1

What is the CDER?

Answer 1

The Center for Drug Evaluation and Research

Question 2

What is the role of the CDER?

Answer 2

To evaluate the safety and efficacy of drugs before they can be sold to consumers.

Question 3

What drugs are regulated by the CDER?

Answer 3

Prescription drugs, generic drugs, and over-the-counter (OTC) drugs; non-medicine drugs such as fluoride toothpaste, antiperspirant deodorants, dandruff shampoos, and sunscreens.

Question 4

What stages of drug development are overseen by the CDER?

Answer 4

The research, development, manufacturing, and marketing of drugs.

Question 5

What are prescription drugs?

Answer 5

Any drugs that require a doctor’s authorization to purchase.

Question 6

What are generic drugs?

Answer 6

Drugs that are equivalent to brand-name drugs in terms of quality and performance.

Question 7

What are over-the-counter (OTC) drugs?

Answer 7

Drugs that are available to consumers without a doctor’s prescription.

Question 8

The CDER oversees the advertising of prescription drugs to ensure what?

Answer 8

That the advertising of prescription drugs is truthful.

Question 9

The CDER monitors the use of marketed drugs for what?

Answer 9

Any unexpected health risks.

Question 10

What actions can the CDER take if they detect any unexpected health risks in an approved drug?

Answer 10

Inform the public
Change a drug’s label
Remove a drug from the market

Question 11

Are generic drugs the same as brand-name drugs?

Answer 11

Yes. The CDER, before approving a generic drug, requires many rigorous tests and procedures to assure that the generic drug can be substituted for the brand-name drug.

Question 12

What types of specifications must be met before a generic drug gets approved?

Answer 12

Identity, strength, quality, purity, and potency.

Question 13

What is therapeutic equivalence?

Answer 13

When a generic drug can be substituted for a brand-name drug.

Question 14

A generic drug must contain what to be considered therapeutically equivalent to a brand-name drug?

Answer 14

Identical amounts of the active drug ingredient found in the brand-name drug.

Question 15

A generic drug deemed therapeutically equivalent to a brand-name drug can be expected to have what?

Answer 15

Equal effect and no differences when substituted for the brand-name drug.

Question 16

A therapeutically equivalent generic drug may differ from a brand-name drug in what characteristics?

Answer 16

Shape, flavor, or preservatives.

Question 17

Why are some drugs changed from prescription to non-prescription drugs?

Answer 17

Some drugs are initially approved as over-the-counter drugs. More often, however, medications are first approved as prescription drugs and then later switched to over-the-counter drugs.

Question 18

How are drugs changed from one type to another?

Answer 18

In one of two ways:

• under an OTC drug review, or
• by a manufacturer’s submission of additional information to the original drug application.

Question 19

What question must be answered when considering a prescription-to-OTC switch?

Answer 19

Whether the drug can benefit consumers without endangering their safety.

Question 20

When are non-prescription or OTC drugs considered safe for consumers to use?

Answer 20

When consumers can easily follow the directions and warnings on the label.

Question 21

To protect consumers, what do FDA regulations require of OTC drugs?

Answer 21

The labeling of OTC drugs must be written so that ordinary people, including those with low reading comprehension skills, are able to easily find and understand information, such as toxicity.

Question 22

What is the major issue in deciding whether to switch a drug from prescription to OTC?

Answer 22

The drug’s toxicity.

Question 23

What is toxicity?

Answer 23

A drug’s potential for poisonous effects.

Question 24

What is another consideration when deciding whether a drug should be available without a prescription?

Answer 24

Whether the condition being treated can be recognized and self-diagnosed without the help of a healthcare practitioner.

Question 25

What are some other factors the FDA evaluates when considering a prescription-to-OTC switch?

Answer 25

• the intended uses and results of the product,
• adequate directions for proper use, and
• warnings against unsafe use, side effects, and adverse reactions.

Question 26

Does the FDA test drugs?

Answer 26

No, the FDA does not develop, manufacture, or test drugs. The CDER receives drug reports from drug manufacturers, analyzes the data in those reports, and weighs the benefits vs. the risks of a drug to determine whether that drug will be approved.

Question 27

Once the FDA approves a drug, does that mean that the product is perfectly safe?

Answer 27

No, no drug is “perfectly” safe. Every drug has some side effects. But since the FDA considers both the benefits and risks of every drug before approval, side effects are generally not serious. The FDA also ensures that the labeling outlines the reported benefits and risks of a drug.

Question 28

What is required for a drug to be approved by CDER?

Answer 28

Proof that it is both safe and effective. CDER decides – as quickly as a thorough evaluation allows – whether the studies submitted by the drug’s sponsor (usually the manufacturer) show the drug to be safe and effective for its intended use. When a drug’s benefits outweigh its risks, CDER considers it safe enough to approve.

Question 29

What is a clinical trial?

Answer 29

A study to evaluate a drug.