Understanding the Drug Approval Process

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Understanding the Drug Approval Process

The Food and Drug Administration (FDA) plays a critical role in the oversight of new drug development: drug approval. New products must initially go through the FDA approval process before they are available to the public at large. Varying consumer-held opinions and misconceptions about these approvals can have a strong influence on public health.

No matter how the public views the FDA’s role, there is ample opportunity to improve consumer understanding about drug research and development. Let’s take a closer look at what this development entails to assist in understanding the drug approval process.

Drug Development Best Practices

Understanding the drug approval process means first understanding its underlying challenges. The pharmaceutical industry faces a wide array of prominent and potential problems throughout the entirety of the lengthy development process.

From initial formulation to final FDA approval, it takes approximately 10 years for a pharmaceutical drug to make it to the marketplace. Despite this long course of operation, scientists around the world strive endlessly towards discovery. Researchers work towards finding cures and solutions for a wide range of illnesses and diseases plaguing humanity today.

Best development practices involve manufacturers, sponsors, and the FDA working closely together to develop high-quality drugs for the American public. Compliance with updated regulatory processes is important throughout the complex, uncertain cycle.

Phases of the Drug Approval Process

The preliminary phases of the process include discovery and initial development through preclinical research on living organisms in lab settings. Once findings are declared safe enough for human testing, the clinical research phase is the next step.

Clinical research is performed through the heavily-involved process of clinical trials. A clinical trial is a scientific term that refers to specific tests and studies of a drug in human bodies to determine if a product is effective and safe for human use.

After a company or sponsor can prove the safety and efficiency of a drug, they must fill out an application for the FDA to review. This reviewal phase involves multiple steps to be taken before the product is available for consumer use.

New Drug Application (NDA) Review

The NDA review includes clinical results, labeling information, patient information, safety information, drug abuse potential, and directions for use. The FDA review team and advisory committee—which contains scientific experts and members of the public alike—reviews the completed application.

After months of consideration about the collected research, analysis data, and manufacturing information, the FDA will decide if the drug is truly safe and effective. Remember, “FDA approval” does not necessarily mean the new drug will help the people who choose to use it or be free from risks. FDA approval suggests that the FDA has decided the benefits of an approved product outweigh its potential risks and validates the need for consumers to be less vulnerable in the modern market.

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