Center for Drug Evaluation and Research (CDER) Flashcards
What is the CDER?
The Center for Drug Evaluation and Research
What is the role of the CDER?
To evaluate the safety and efficacy of drugs before they can be sold to consumers.
What drugs are regulated by the CDER?
Prescription drugs, generic drugs, and over-the-counter (OTC) drugs; non-medicine drugs such as fluoride toothpaste, antiperspirant deodorants, dandruff shampoos, and sunscreens.
What stages of drug development are overseen by the CDER?
The research, development, manufacturing, and marketing of drugs.
What are prescription drugs?
Any drugs that require a doctor’s authorization to purchase.
What are generic drugs?
Drugs that are equivalent to brand-name drugs in terms of quality and performance.
What are over-the-counter (OTC) drugs?
Drugs that are available to consumers without a doctor’s prescription.
The CDER oversees the advertising of prescription drugs to ensure what?
That the advertising of prescription drugs is truthful.
The CDER monitors the use of marketed drugs for what?
Any unexpected health risks.
What actions can the CDER take if they detect any unexpected health risks in an approved drug?
Inform the public
Change a drug’s label
Remove a drug from the market
Are generic drugs the same as brand-name drugs?
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.
What types of specifications must be met before a generic drug gets approved?
Identity, strength, quality, purity, and potency.
What is therapeutic equivalence?
When a generic drug can be substituted for a brand-name drug.
A generic drug must contain what to be considered therapeutically equivalent to a brand-name drug?
Identical amounts of the active drug ingredient found in the brand-name drug.
A generic drug deemed therapeutically equivalent to a brand-name drug can be expected to have what?
Equal effect and no differences when substituted for the brand-name drug.
A therapeutically equivalent generic drug may differ from a brand-name drug in what characteristics?
Shape, flavor, or preservatives.
Why are some drugs changed from prescription to non-prescription drugs?
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.
How are drugs changed from one type to another?
In one of two ways:
- under an OTC drug review, or
- by a manufacturer’s submission of additional information to the original drug application.
What question must be answered when considering a prescription-to-OTC switch?
Whether the drug can benefit consumers without endangering their safety.
When are non-prescription or OTC drugs considered safe for consumers to use?
When consumers can easily follow the directions and warnings on the label.
To protect consumers, what do FDA regulations require of OTC drugs?
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.
What is the major issue in deciding whether to switch a drug from prescription to OTC?
The drug’s toxicity.
What is toxicity?
A drug’s potential for poisonous effects.
What is another consideration when deciding whether a drug should be available without a prescription?
Whether the condition being treated can be recognized and self-diagnosed without the help of a healthcare practitioner.
What are some other factors the FDA evaluates when considering a prescription-to-OTC switch?
- the intended uses and results of the product,
- adequate directions for proper use, and
- warnings against unsafe use, side effects, and adverse reactions.
Does the FDA test drugs?
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.
Once the FDA approves a drug, does that mean that the product is perfectly safe?
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.
What is required for a drug to be approved by CDER?
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.
What is a clinical trial?
A study to evaluate a drug.
