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.
At Shehadeh Giannamore, we are committed to providing comprehensive regulatory assistance to a diverse clientele throughout the United States and abroad. Contact us today at (305) 507-9843, or visit us online for more details about our FDA attorney.
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.
Whether you are looking for an FDA attorney, FDA lawyer, or FDA consultant, we can help! Call us today at (305) 507-9843, or visit us online for more details about our FDA lawyer.
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.
We provide a range of FDA attorneys, FDA lawyers, and FDA consultant services to help businesses become FDA compliant. Contact us now at (305) 507-9843, or you can visit us online for more details about our FDA consultant.
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:
At Shehadeh Giannamore, we are committed to providing comprehensive regulatory assistance to a diverse clientele throughout the United States and abroad. Call us now at (305) 507-9843, or you can also visit us online for more details about our FDA attorney.
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.
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.
We provide a range of FDA attorneys, FDA lawyers, and FDA consultant services to help businesses become FDA compliant. Contact us now at (305) 507-9843, or visit our website for more details about our FDA lawyer.
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.
At Shehadeh Giannamore, we are committed to providing comprehensive regulatory assistance to a diverse clientele throughout the United States and abroad. Call us today at (305) 507-9843, or visit us online for more details about our FDA attorney!
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.
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.
At Shehadeh Giannamore, PLLC, our experienced FDA lawyers can give you critical legal advice about products that required an FDA premarket approval. Call us now at (305) 507-9843, or you can also visit our website for more details.
