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What Does “FDA-Approved” Really Mean?

What Does “FDA-Approved” Really Mean?

May 3, 2022 | Pharmaceutical Litigation

When you see the term “FDA-approved” on a product, it’s easy to think that it’s been verified as safe and effective by the government agency.

But what does that really mean?

In this article, we’ll discuss what “FDA-approved” actually means as well as the process of getting a product, specifically pharmaceuticals, FDA-approved.

Understanding the process and what “FDA-approved” actually means can help you determine whether or not you’ve been harmed by an FDA-approved product.

How Do Pharmaceuticals Gain FDA Approval?

Before a pharmaceutical can be marketed in the United States, it must go through a rigorous approval process with the FDA. The FDA has a number of requirements that must be met before a drug can be approved, including:

  • The drug must be safe and effective.
  • The drug must be manufactured according to good manufacturing practices (GMPs). GMPs are a set of regulations that ensure that drugs are made safely and according to quality standards.
  • The drug must be properly labeled. The label must include the name of the drug, the dosage, and the directions for use. The label must also warn about any potential risks and side effects.
  • The drug must be accompanied by a patient package insert (PPI). The PPI is a document that provides information about the drug for patients. It includes information about the drug’s uses, potential risks, side effects, and how to take it.

Before a new drug can be marketed, the manufacturer must submit an investigational new drug application (IND) to the FDA.

An IND is a request for permission to test a new drug in humans. The FDA will review the application and may ask for more information. 

If the FDA agrees to let the manufacturer test the drug, it will be placed in what’s called a clinical hold. A clinical hold is when the FDA stops a clinical trial because of safety concerns.

The manufacturer must also submit a new drug application (NDA) to the FDA. The NDA is a comprehensive report on the drug that includes data from pre-clinical and clinical studies. The FDA will review the NDA and may ask for more information. 

If the FDA agrees to let the manufacturer sell the drug, it will be placed in what’s called a final approval hold. A final approval hold is when the FDA stops a drug from being sold because of safety concerns.

The approval process for a new drug can take many years. The FDA may request more information from the manufacturer at any time during the approval process.

What Does “FDA-Approved” Mean?

The term “FDA-approved” is used to describe products that have been approved by the Food and Drug Administration (FDA).

But what does that mean? In most cases, it just means that the manufacturer has submitted information about the product to the FDA and received approval for it to be marketed.

The FDA doesn’t actually test products itself; it relies on data provided by the manufacturers.

What if You’re Harmed By an FDA-Approved Product?

If you’ve been harmed by an FDA-approved product, you may be able to file a lawsuit against the manufacturer.

The FDA has a number of safety regulations that must be followed before a drug can be marketed, and manufacturers are responsible for complying with these regulations.

If they don’t, they can be held liable for any injuries caused by their products.

Different parties may be liable depending on whether the manufacturer made false claims or the proper instructions for taking the medicine weren’t given.

Contact Napoli Shkolnik

If you’ve been harmed by an FDA-approved product, it’s important to speak with a lawyer who can help you determine if you have a case. Contact Napoli Shkolnik’s team of professionals today for a free, no-obligation consultation.

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