Things To Know About the FDA Approval Process

From drinks to medications, Americans consume so many products on a daily basis. But before these products can hit the shelves, the FDA (Food and Drug Administration) must oversee the entire process of approving these products for human consumption. Its attention to detail keeps everyone safe. To give you better peace of mind before you consume a new food or drug, here’s what you need to know about the FDA approval process.

The Initial Process

First, the Center for Drug Evaluation and Research (CDER) reviews, examines, and evaluates all new drugs seeking FDA approval. The FDA considers this organization to be the watchdog of the approval process because it can catch any problems from the very beginning.

The approval process begins once the CDER receives an application from the company that manufactured the drug. This application includes:

  • The drug’s test results
  • Data that demonstrates the company’s ability to properly manufacture the drug
  • Data the company gathered during any animal studies and during human clinical trials
  • The company’s proposed label for the drug, which should include any risks and directions for usage

The CDER employs a group of highly trained and experienced chemists who perform a series of experiments and tests to fish out any concerns and discover the true nature of the drug in question.

Reasons for Denials

If the company fails to prove the drug’s effectiveness or does not show correct safety procedures, the FDA may deny approval for the drug. The FDA will give detailed reasons for its denial. The pharmaceutical company will then review the reasons, and it still has a chance to appeal the denial. The appeal entails the company asking for a hearing with the FDA; if the company has any new information or new developments it wishes to share, it can do so at the hearing. The company can then attempt to correct any mistakes and resubmit the application.

Accelerated Approvals

Some drugs get quicker approval than others. This isn’t preferential treatment; the FDA often expedites or accelerates approvals for drugs that may treat life-threatening illnesses. For example, the FDA will likely approve new developments for cancer more quickly than it will approve medicines used to treat headaches. The new drug needs to show signs of improved therapeutic benefits over currently available therapies.

Continued Monitoring

Even after the FDA approves a new drug or food, it will continue to monitor the product. It doesn’t just wash its hands of the product and then move on. It will stick with the product because Americans’ health and safety are its main priorities.

A few teams help the FDA with the continued monitoring. For example, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services (CMS) also help with the monitoring process. With so many helping hands, you can safely consume as many FDA-approved products as you want without worrying about how they might affect your immune system.

Now that you know a little more about the FDA’s approval process, you can trust this organization to tell you which products you can safely consume.