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November 2019
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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. At Shehadeh Giannamore, PLLC, we provide a range of FDA attorneys, FDA lawyers, and FDA consultant services to help businesses become FDA compliant. Call us now at (305) 507-9843, or you can also visit our website for more details.
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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. If you need help with labeling and registering and listing your products with the FDA, you're in the right place! Call Shehadeh Giannamore, PLLC now at (305) 507-9843 for the best FDA attorney services, or you can also visit our website for more details.
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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.
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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.
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FDA has particular requirements for the labels of the products it regulates, including the supplement facts panels of dietary supplements. In particular, the FDA requires certain statements to be made on the Principal Display Panel (PDP) of many FDA-regulated products, such as the Net Quantity of Contents, Statement of Identity, etc. However, it must be noted that the label requirements differ based on product classification. If you would like to know more about our reviews of supplement facts panels or how an FDA regulatory attorney can help you ensure FDA compliance, please feel free to contact Shehadeh Giannamore, PLLC at (305) 507-9843. You can also visit us online for more details.
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When marketing a medical device, you will need clearance from the Food and Drug Administration (FDA). It is a rigorous process, and there are substantial fees. Medical device falls under three classes, and required submissions will depend on what class your device is assigned. Information relevant to the FDA approval process is broken down into sections below so that you can easily follow through the steps. Interested in working with an experienced FDA compliance consultant, contact Shehadeh Giannamore, PLLC at (305) 507-9843 for the best FDA compliance services. You can also visit us online for more details.
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Because the FDA generally classifies the products based on intended use and ingredients, among other considerations, an initial stage in determining how a product will be regulated is by looking to the intended use. The FDA generally determines the intended use of a product based on statements, called “claims,” made about a product, i.e., what the marketer claims the product can do. Nutrient content claims are particular claims made about the ingredients found in products and the nutritional value thereof. For more information about hiring an FDA regulatory lawyer or how we may help develop nutrient content claims or other types of labeling claims that are compliant with FDA regulations, please contact Shehadeh Giannamore, PLLC at (305) 507-9843 for the best FDA attorney services. You can also visit us online for more details.
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Because the FDA typically regulates products based on both their intended use and ingredients found therein, an initial stage in determining how a product is regulated is by looking to the intended use. The FDA gleans the intended use of a product based on statements, called “claims,” made about a product, i.e., what the marketer claims the product can do. These claims may be made on product labels, through infomercials or other marketing materials and on product websites. For more information about how an FDA regulatory attorney can help you by conducting website reviews to help you achieve compliance with FDA regulations, please contact Shehadeh Giannamore, PLLC at (305) 507-9843 for the best FDA attorney services. You can also visit us online for more details.
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To ensure that businesses are following safety rules and regulations set by the U.S. Food and Drug Administration (FDA), the agency will periodically perform on-site inspections of those businesses. Sometimes the inspections occur without notice. Because of this, it is essential to ensure that you are ready to pass an inspection at any time. If you would like to learn of other ways you can pass an inspection, contact Shehadeh Giannamore, PLLC at (305) 507-9843 for the best FDA consultant. You can also visit us online for more details.
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Reconditioning is a process where the FDA allows importers of non-compliant products to bring these goods into compliance with federal regulations. Once compliance is achieved, these products may be released and sold to consumers. Accordingly, it is essential to determine the best course of action when handling import issues and reconditioning requests. If you have any questions about hiring an FDA regulatory attorney for your import-related matters or how we may be able to help you with import issues and reconditioning requests, please feel free to contact Shehadeh Giannamore, PLLC at (305) 507-9843. You can also visit our website for more details about our FDA attorney services.
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