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November 2019
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The federal register is one of the most important sources for information on what FDA -- or for that matter, what any government agency is doing. Published daily, Monday through Friday, the federal register carries all proposed and finalized regulations and many important legal notices issued by the various agencies, as well as presidential proclamations and executive orders.We provide regulatory guidance and FDA compliance services to a wide variety of clients who need assistance with establishing and maintaining full compliance with federal laws and regulations. Call us today at (305) 507-9843 or visit us online 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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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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Individuals around the world are looking for the best nutritional content in the packed food and supplements that they want to consume. Everybody is cautious of their weight while some individuals are allergic to specific food components. Even so, there are standards set by the FDA to ensure all food and drug products meet the required minimum values. Hence, either way; as a producer or consumer, you may have to make or respond to FDA Nutrient Content Claims to demand that you get a relevant attorney to help you win. Whether you are looking for an FDA attorney, FDA lawyer, or FDA consultant, we can help! Call us at (305) 507-9843. You can also visit our website for more details about our FDA attorney services.
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