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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 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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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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To get FDA approval, drug manufacturers must conduct lab, animal, and human clinical testing and submit their data to the FDA. FDA will then review the data and may approve the drug if the agency determines that the benefits of the drug outweigh the risks for the intended use. For additional questions regarding how to get FDA approval and other FDA regulations, please feel free to contact Shehadeh Giannamore, PLLC at (305) 507-9843. You can also visit our website for more details about our FDA lawyer services.
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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 must be noted that the label requirements differ based on product classification. When products are packaged in both outer and inner containers, the general labeling requirements may vary. If you would like to know more about outer packaging requirements or how we can help you ensure that your labels comply with FDA regulations, please feel free to contact us at (305) 507-9843 for the best FDA consultant services. You can also visit us online for more details.
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Our FDA Consultant Services are comprehensive and industry and product-specific to help our clients develop products that are compliant with federal laws and regulations. From ingredient reviews to label reviews, FDA registration, and marketing reviews, we provide extensive FDA Consultant Services to meet the needs of clients at every level and stage in the manufacturing and marketing process. If you would like to know more about the FDA Consultant Services or how hiring an FDA regulatory attorney can help you ensure that your labels comply with the FDA regulations, please feel free to contact us today at (305) 507-9843.
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Under FALCPA and accompanying FDA regulations, major allergens must be declared in the labeling of all food products (including dietary supplements) sold in the United States. If the significant allergens are not appropriately stated, companies face the possibility of detention/refusal, warning letters, and (because allergens invoke serious health risks to consumers) even recalls. Accordingly, it is essential for marketers to stay up-to-date with current labeling regulations to avoid costly mistakes. For more information about food regulations or our services, call Shehadeh Giannamore, PLLC at (305) 507-9843. You can also visit our website for more details about our FDA consultant services.
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