FDA Lawyer - Health Claims and Label Reviews

While there are different types of claims, i.e., health claims, disease claims, structure-function claims, some claims may cause a product to be subject to heightened regulation. For example, if a product is otherwise classified as food, but its labeling contains disease claims, the FDA will classify this product as a drug. On the other hand, certain claims, called structure-function claims, may be made about dietary supplement products and, if done correctly, will not cause these products to be subject to heightened regulation.

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FDA Attorney Services - How Does A New Treatment Get FDA Approval?

When a drug or treatment enters the clinical trial process, it must pass through three phases of testing before becoming eligible for the Food and Drug Administration (FDA) approval. Only if the treatment proves to be safe and promising at each phase, is it allowed to proceed to the next phase of testing.

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FDA Consultant - FDA Label Reviews And FDA Regulations

FDA label reviews and marketing reviews are key tools that we use to help our clients comply with FDA regulations and related federal laws. Since the FDA generally classifies the products it regulates based on the intended use and ingredients found therein, an initial stage in determining how a product is regulated is by looking to the intended use thereof.

If you still need questions with FDA label reviews and FDA regulations, we've got you covered. Shehadeh Giannamore, PLLC, can assist you with establishing the best FDA compliance services! Give us a call now at (305) 507-9843, or you can also visit our website for more details.

FDA Attorney - Importance of FDA Warning Letter Responses

While warning letters are considered an informal mechanism of agency action, the failure to respond appropriately may often result in more formal measures being taken against non-compliant firms. Because appropriate corrective measures often preclude further enforcement, it is critical to be vigilant when preparing FDA a warning letter response to perceived deficiencies in compliance. Accordingly, an FDA regulatory lawyer can allow you to develop a warning letter response that can help you avoid further agency enforcement.

For more information about hiring an FDA regulatory lawyer to help you respond to FDA warning letters or how you can achieve FDA compliance, please feel free to contact us now at (305) 507-9843. You can also visit our website for more details about our FDA attorney services.