About FDA
FDA Basics: Drugs
FDA Basics
Over-the-counter and prescription drugs, including generic drugs, are regulated by FDA's Center for Drug Evaluation and Research (CDER). This work covers more than just medicines.
For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered "drugs."
Do You Know…
How a New Prescription Drug is Approved?
Drug companies seeking FDA approval to sell a new prescription drug in the United States must test it in various ways. First are laboratory and animal tests. Next are tests in humans to see if the drug is safe and effective when used to treat or diagnose a disease. More…
FDA Basics Videos
 Watch a video about FDA's role in the development, testing, and monitoring of new drugs | John Jenkins, director of the Office of New Drugs in the Center for Drug Evaluation and Research, looks at changes in the way new drugs are evaluated. Watch FDA Basics Videos... |
Drug Approval
Is it true FDA is approving fewer new drugs lately? Is the U.S. really slower than Europe in approving new drugs? What is the approval process for a new prescription drug? What are over-the-counter (OTC) drugs and how are they approved? What are generic drugs and how are they approved? Are generic drugs the same as brand name drugs? How do I find out if a drug is approved? Is there a Web site I can go to? How can I get access to a drug that is in testing but has not yet been approved? Why do some drug labels get changed so often ? Does FDA approve the proprietary names of prescription drugs? What are unapproved drugs and why are they on the market?
Information About Drugs
Where can I find information about medicines prescribed for my child? Where can I find information about adverse reactions to a medicine prescribed for my child? What are the possible side effects of a drug and where can I find the most current information about my drug? Does FDA approve the information given out by pharmacies when I pick up my medicine? Can FDA ban direct-to-consumer drug advertising? How does FDA help consumers when drug shortages happen? How do I discard medicine that I no longer need, do I just throw it in the garbage? How can I stay better informed about drugs? Is there a reliable website FDA recommends?
Safety
How does FDA monitor safety after drugs are approved and marketed? - How does the Center for Drug Evaluation and Research ensure that drugs are safe and effective?
How does FDA decide when a drug is not safe enough to stay on the market? What is a Warning Letter? Why isn’t a drug taken off the market when a manufacturer gets a Warning Letter? How does FDA oversee domestic and foreign drug manufacturing? What does FDA require drug manufacturers to do to prevent contaminated drugs? If contamination occurs, how must they correct the problem? How do I report a bad reaction to medicine or medication error to FDA? What is an FDA Drug Safety Communication?
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