The FDA Drug Approval Process

Before a new drug is available to the public, it must undergo a strict and structured period of testing and analysis by the FDA’s Center for Drug Evaluation and Research (CDER). This approval process ensures that prescription medications are safe and effective; and the health benefits of a medication outweigh any of its potential risks.

The clinical research studies held at Synergy Research Centers are an important step in the drug approval process. But the research and journey toward bringing new medications to market begins well before these studies take place – and continues long after they’re completed.

Preclinical Research: Before Clinical Trials Begin

New drugs are discovered and developed by sponsors in a laboratory, where researchers conduct a number of experiments to collect information on the drug’s benefits, risks, efficacy, and methods of action. Researchers also determine the best way to administer the drug and the ideal dosage.

Before human testing can begin, the drug must first go through a round of animal testing. This is to ensure it doesn’t have the potential to cause serious harm. Once the drug passes toxicity tests in animals, researchers can study the way it behaves in the human body through the use of clinical trials.

To initiate the process, the drug sponsor must submit an Investigational New Drug application to the FDA with a plan for human testing – also known as a protocol – including who can participate, how many people will take part, and how long the study will last. The CDER evaluates this plan to ensure the safety of all participants. If approved, clinical trials can begin.

The Three Phases of Clinical Trials

Clinical trials generally take place in three phases:

  • Phase 1

The first phase is the smallest, shortest phase, lasting for several months and generally includes between 20 and 100 volunteers. The purpose of this phase is to ensure the drug is safe and to establish an ideal dosage. About 70% of drugs tested pass this phase and move onto the next one.

  • Phase 2

Several hundred people usually participate in the second phase of drug trials, for a period of anywhere from a few months to two years. This phase focuses on determining drug efficacy and identifying any potential side effects. About 33% of drugs in this phase move onto the last phase before an application for market approval is submitted.

  • Phase 3

The final phase before a drug is submitted for FDA approval can have thousands of participants and last for several years. At this time, researchers gather more information on the efficacy of the drug while monitoring participants for side effects or potential compromising factors. Around 25% to 33% of drugs in Phase 3 move on for final FDA review.

FDA Drug Review and Ongoing Risk Assessments

When all clinical studies for a new medication have completed successfully, the drug sponsor will submit a New Drug Application (NDA) to the FDA. The NDA includes all data collected from both preclinical and clinical research studies, details about how the drug behaves in the human body, and descriptions about how the drug is manufactured. A team of experts from the CDER, including physicians, statisticians, chemists, and pharmacologists, review the NDA to decide whether or not to approve the drug. During this time, the team meets with the drug sponsor and tour the facilities where the drug is produced. 

Once a drug is approved, it is released to the market for public consumption, where it is closely monitored by the FDA. Programs like MedWatch and MedSun allow drug manufacturers, health professionals, and patients to report problems they may encounter. The drug sponsor is also required to submit periodic updates to the FDA. Strict, ongoing oversight like this helps to keep everyone safe and healthy while ensuring access to the best available therapeutic treatments.

Clinical Trials at Synergy Research Centers

Advances in science and medicine rely on clinical trials like those conducted at Synergy Research Centers. If you’re interested in participating in one of our inpatient or outpatient clinical research studies in San Diego, contact us today at (888) 539-0282.