How to get FDA approval depends on the type of product you are marketing in the United States. FDA does not require FDA approval for all types of product. Please read the following information below to find out which products require FDA approval and how to obtain it when necessary. FDA compliance consultants can help you to get FDA approval easily.
FDA Approval of Food, Beverages and Food Supplements
FDA does not approve foods, beverages, or food supplements. Food establishments do not have to obtain any type of certification or approval before distributing their products in the United States. Food establishments require registration with the FDA, but being registered with the FDA does not indicate an FDA approvals of the establishment or its products.
New food additives require FDA approval. If a manufacturer wants to use a new food additive in their product, he will need to submit the additive to appropriate analysis and prove to FDA that the additive is safe. FDA compliance training is must for the FDA consultant.
FDA Approval for Medications
Whether or not a new drug requires FDA approval depends on whether the new drug conforms to an over-the-counter (OTC) monograph. Once an OTC monograph by FDA compliance consultants is finalized, drug establishments may market OTC drugs that conform to the monograph without FDA approval. An FDA compliance consultant also uses the application at its discretion to allow certain drugs to be marketed without approval if they conform to tentative final monographs.
If a new drug does not comply with a monograph, it will require FDA approval. To obtain FDA approval, drug manufacturers must conduct laboratory tests, animal and human clinical tests, and submit their information to FDA. FDA will review the information and may then approve the drug if the agency determines that the drug's benefits outweigh the risks for its intended use. Marketing a new drug that is not in compliance with an OTC monograph and without an FDA approval is considered to be marketing a new unapproved drug, which is a prohibited act under the Food, Drug and Cosmetic Act (FD&C Act). A good consultant must undergo FDA compliance training is must for the FDA consultant.
Although FDA approves new drugs, the agency does not approve compound drugs for a single patient. Drug establishments must register with FDA and list their products, but neither registration nor listing indicates FDA approval of the establishment or its products.