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.
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!
