We provide a range of FDA attorney, FDA lawyer and FDA consultant services to help businesses become FDA compliant. We serve a global clientele in any location.
With approved packaging from the Food and Drug Administration, it means that the materials are safe to contain food products. You won’t have to wonder about the safety of your packaging materials, and neither will your customers.
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. Feel free to contact us today at (305) 507-9843, or you can also visit us online for more details about our FDA attorney.
The FDA, or Food and Drug Administration, is a government agency operating under the United States Department of Health and Human Services (HHS). The FDA is primarily responsible for regulating medical products and tobacco, foods and veterinary medicine, and global regulatory operations and policy.
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The FDA Center for Drug Evaluation and Research (CDER) is the watchdog for potential medications seeking approval for use in the United States. For CDER to begin evaluating a drug, pharmaceutical companies must first do extensive testing and document the results. Those results are sent into the CDER, which assigns a team of doctors, chemists, pharmacologists, and other scientists to review the evidence.
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Guidance documents represent the agency's current thinking on a particular subject. These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products.
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FDA approval of a drug means that CDER has reviewed data on the drug's effects, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population. The drug approval process takes place within a structured framework that includes:
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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.
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The FDA has particular requirements for the labels of the products it regulates. 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 is essential to note that the label requirements differ based on product classification. For example, while food labels must bear Nutrition Facts Panels, dietary supplements (although a subset of the food classification) are required to display Supplement Facts Panels.
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Because the FDA generally classifies the products it regulates based on intended use and ingredients found therein, 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. By understanding the types of claims under FDA regulations and federal law, we can help you avoid making disease claims that may cause your products to be regulated as drugs inadvertently.
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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.
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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.
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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.
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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.
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The 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.
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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.
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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.
Premarket notification or “510k clearance” is a prerequisite to the marketing and sale of most Class II medical devices. In order to secure a 510k clearance, device sponsors must demonstrate a device’s substantial equivalence to previously cleared devices or be considered substantially equivalent to a device that has been marketed prior to May 28, 1976.
Should you have any questions about your device or how an FDA regulatory attorney may help you with the 510k submission process, 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.
The Food and Drug Administration's regulatory approaches to marketing approval of the products it regulates are as varied as the products themselves. These differences are dictated by the laws FDA enforces and the relative risks that the products pose to consumers. Below is a list of the type of products that are regulated by the federal government.
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The U.S. Food and Drug Administration (FDA) examines, tests, and approves a wide range of items for medical use, including drugs, medical devices, food, cosmetics, and many other health-related products. In the simplest terms, "FDA approval" means that the FDA has decided the benefits of the approved item outweigh its potential risks. Now, new products must go through the FDA approval process before they are available to the public.
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FDA is a US federal agency responsible for the security and efficacy of food products. FDA compliance is an essential aspect of maintaining pharmaceutical quality and standards. Pharma and biotech companies need to ensure they follow pharmaceutical cGMP (current Good Manufacturing Practice) guidelines to ensure that products don’t pose a risk to public health and safety.
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It's up to pharmaceutical executives to ensure the appropriate agencies approve medical products and marketed appropriately. However, this can pose a challenge given the changing guidelines of agencies such as the Food and Drug Administration (FDA). With these challenges in mind, many pharmaceutical executives choose to enlist the expertise of a consulting firm that specializes in compliance with regulatory guidelines.
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