What Is the FDA Approval Process?

Perceptive-Regulatory Consulting, operating out of Burbank, California, is run by Robert Gadimian. Robert Gadimian is also a part of different professional regulatory affairs groups and societies. Perceptive-Regulatory Consulting provides regulatory affairs support to companies and their pre-developed products to get approval from the Food and Drug Administration (FDA).

Getting FDA- approved is the only way to distribute products in the United States legally. However, depending on the product, FDA approval can be fast and easy or long and difficult.

The FDA approval process looks different depending on the product being registered with them. To begin, FDA approval for food is dependent on the manufacturer or the distributor self-regulating their product. Manufacturers and distributors still need to follow the guidelines and labels that the FDA requires all food products to have. For drugs, the approval process looks a little different.

The FDA reviewers analyze the condition or illness for which the proposed drug is designed to treat. They do this by evaluating the current treatment methods used in the United States, which helps the FDA assess the drug’s risks and benefits. The FDA also comes with risk management strategies, including placing an FDA-approved label with clear statements that describe the benefits and risks of the drug and how the risks can be detected and managed by the potential consumer.

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Robert Gadimian

A Burbank, California-based regulatory affairs professional, Robert Gadimian serves as president of Perceptive Regulatory Consulting.