How Does the FDA Approve Drugs?

Updated on June 3, 2021

The U.S. Food and Drug Administration (FDA) is the primary watchdog in one of the world’s most advanced pharmaceutical systems. Its most well-known job is to evaluate new drugs before they can be sold to the public. It provides healthcare providers and patients with the information they need to use these treatments wisely while ensuring that new drugs are effective for the condition they aim to treat and that the benefits outweigh their risks.

The FDA’s Center for Drug Evaluation oversees the entire drug approval process before the medicine is marketed. The full research, development, and approval process can last 10 to 15 years or even more. This is what happens during this time period to ensure that when you pick up your medication at the pharmacy, it will be both safe and effective.

Initial Investigation Phase

The early phases of the approval process includes preclinical research to screen a potential drug for toxicity in animals before it can move forward to human trials. The sponsor must test it on various types of animals for toxicity to generate data on the efficacy and safety of the compound being investigated. When the data is encouraging an application is filed with the FDA detailing specifics like pretesting details, the composition of the drug, and the plans for human testing. The application is reviewed to ensure that the clinical trials will be safe for human participants and that proper informed consent is included to protect them.

When a pharmaceutical company like Adare Pharmaceuticals develops a drug, it will undergo several years of lab testing before the application is made to the FDA so that human drug testing can begin. Just one in 1000 of compounds that enter lab testing will ever move on to the human testing phase.

Phase 1

There are three phases of clinical trials once the FDA gives the go ahead for the drug. During the first phase, investigators spend several months to a year looking at the effects of the medicine on approximately 20 to 100 people to determine its safety and profile, with an emphasis on safety, metabolism, and excretion. The aim of this phase is to find the highest dose humans can take without having any serious side effects. Participants are carefully watched to determine how their bodies react to the drug. The searchers also look at optimal ways to administer the drug, be it topically, intravenously, or orally.

Phase 2

More participants take part in the next stage of the process once the drug passes the first. It typically involves about several hundred who have the same condition the new medicine aims to treat. They’re usually provided with the same dose show to be effective in the previous phase.

They’ll be monitored for several months or as long as several years to determine how effective it is while gathering information about the side effects people experience. The data that’s collected will help the investigators come up with the methods they’ll use in the third phase.

Phase 3

In the third phase, several thousands of participants of various age ranges and types will typically be monitored in hospitals and clinics to identify further side effects and efficacy. The manufacturer might look at the effects of the drug when combined with other treatments as well as different doses. From start to finish, this phase takes an average of about three years.

FDA Application

Once the pharmaceutical company files the application with the FDA, the FDA will review all of the clinical information that’s taken place to date and take action to inspect any manufacturing plants where it will be made. The FDA Advisory Board will meet to discuss the application with the manufacturer of the drug. Afterwards, the board will make a recommendation to approve or deny. The FDA frequently follows this advice but isn’t obligated to do so. Once it is approved, the medication will then be available for doctors to prescribe.

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