Overview of our role regulating and approving drugs | Video series
Learn how we use science and data to ensure their safety, quality and efficacy
What is FDA’s role in regulating drugs?
You may know the FDA is responsible for approving new drugs, such as prescription, generic, biosimilars, and over-the-counter drugs, and ensuring those drugs are safe, high quality, and work the way they’re supposed to. But our work doesn’t end there. We continue to monitor approved drugs for safety and quality for years to come. Learn more about our role in the regulation of these drugs.
You may know the FDA is responsible for approving new drugs and making sure those drugs are safe, high quality, and work the way they’re supposed to.
But HOW is it done? How are decisions made, and are those decisions in your best interest? What else does the FDA do--and NOT do?
These are important questions! And the FDA understands the importance of asking and answering questions -- because that’s exactly what it does.
The highly trained staff in the FDA’s Center for Drug Evaluation and Research are committed to protecting the public’s health, advancing science, and regulating human drugs.
These staff analyze data, evaluate research, and make decisions based on science to ensure that prescription, generic, biosimilars, and over-the-counter drugs work correctly. They use science and data to ask – and answer – questions like:
- Is this new drug safe?
- Does it work the way it’s supposed to?
- Do the benefits of this drug outweigh the risks?
And once drugs are approved, the FDA monitors them for safety and quality for years to come.
This thorough analysis helps the FDA provide the timely information health care providers and patients need to choose treatments wisely.
The FDA’s decisions are not influenced by industry or politics. The FDA’s decisions are guided by science and data.
It’s important to know that the FDA oversees clinical trials for safety and reviews the resulting data. However, the FDA does NOT conduct clinical trials.
FDA also does NOT control the cost of drugs or get involved in interactions between patients and their health care providers.
As part of its public health mission, the scientists and staff at FDA work to protect the American public by getting the accurate, science-based information they need to use medications wisely. All by asking questions and letting science lead to the answers.
Questions about the FDA and human drugs? Find the answers at www.fda.gov/drugs.
How does the FDA approve new drugs?
Prescription drugs go through many important steps and phases before they’re approved by us. Research, data, and evidence must show that each drug is safe and effective for its intended use. Learn more about FDA’s approval process from beginning to end.
When you reach for your prescription medications, you trust that the medicine is going to do what it’s supposed to do – make you feel better!
That trust comes from knowing that teams of doctors, biologists, chemists, pharmacists and other health scientists at the FDA are working tirelessly to protect the health of the American public by making careful, informed decisions about which new drugs to approve.
So how does the FDA determine if a drug is safe and effective?
It follows a comprehensive, multistep process that includes many steps and check points.
First, a drug maker develops a drug to help treat a disease or medical problem, then they test it in a lab.
If these preliminary tests go well, the drug maker fills out an Investigational New Drug Application and submits it to the FDA. This application explains how the drug maker plans to investigate and test the drug in clinical trials on volunteers. These clinical trials, which can take about 6 years to complete, must follow a set of laws and regulations that are meant to protect the rights, safety, and welfare of volunteers.
There are typically three phases in a clinical trial, with each phase involving more patients. It’s important to remember that the FDA does NOT develop new therapies or conduct clinical trials; however, FDA DOES have rules to ensure they remain safe.
Once the drug maker has conducted the clinical trials and has gathered enough data to show the drug is safe and effective, they can submit a New Drug Application to get that drug approved by the FDA.
At this point, an unbiased team of FDA experts evaluates the clinical trial research and scientific data to determine if it meets FDA’s rigorous standards. The FDA asks questions like, is this drug safe? Does it work the way it should? Is it high-quality? Do its benefits outweigh its known risks?
If the answers are yes, the FDA then inspects the facility where the drug will be made to make sure it meets the FDA’s standards for manufacturing.
If the FDA team determines that the research, data, and evidence shows that the drug is safe and effective for the intended use, the FDA approves the drug.
Once a drug is approved and patients begin taking it, the FDA continues to monitor the drug’s safety, effectiveness, and quality for years to come.
The process to develop and then approve a medication can take several years; it’s a sign that the FDA is committed to protecting patients. So, the next time you pick up that prescription medication, you can trust that it’ll do what you need it to do, safely and effectively.
Questions about the FDA or the clinical trials? Learn more at www.fda.gov/drugs.
What does the FDA do after drugs are approved?
FDA continuously monitors real-time data from patients, drug manufacturers, and health care professionals, including reports of adverse reactions to prescriptions. Based on this data, we may update drug labeling, or, in rare cases, request a drug recall. Learn more about FDA’s process for the continuous monitoring of approved drugs.
When you fill a prescription from your doctor, you trust that it will be safe and effective. That trust comes from knowing that teams of doctors, biologists, chemists, pharmacists, and other health scientists at the FDA made informed decisions about which drugs to approve, based on science and data.
But what happens after drugs are approved? HOW does the FDA continue to monitor them for years to come, and WHY is this so important?
The FDA conducts a thorough analysis to ensure that prescription drugs are ONLY approved after three phases of clinical trials have shown they are high-quality, safe, and work as they should. These trials can involve hundreds, or sometimes thousands, of people.
But once the drug is on the market and available to patients for use, new data about safety and effectiveness can come to light. The FDA keeps track of that new data, which can come from patients, drug makers, or health care professionals, and may include information about negative reactions to prescriptions.
Based on this information, the FDA may recommend that the drug maker update the drug labeling by adding warnings or updated dosage information. Changes could also include the FDA requesting a drug recall, but the need for that is rare.
The FDA also conducts ongoing inspections of facilities where drugs are made to make sure that drug companies are following quality and safety standards.
The FDA keeps track of all this drug data and makes sure the public stays informed. You can find information about drug recalls through your health care providers and other trusted sources of health information, such as FDA’s MedWatch page, where patients can also report safety concerns.
All of these safety measures—including requesting recalls from companies—are a sign that the FDA is doing its job. By closely monitoring drugs in development, at approval, and years after, the FDA looks out for you, by ensuring that the medicines you rely on are safe and effective.
Questions about the FDA? Find the answers at www.fda.gov/drugs.