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3881 fillable FAQ
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The Food and Drug Administration (FDA) is an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices.
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To obtain an FEI number for a GDUFA-related facility, email FDAGDUFAFEIRequest@fda.hhs.gov. To obtain an FEI number for a PDUFA- or BsUFA-related facility, email PDUFABSUFAFEIRequest@fda.hhs.gov. Note: An FEI number is a facility specific identifier.
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To apply to market a new drug, biologic, or an antibiotic drug for human use, you need to complete Form 356h. Form 356h includes information such as applicant information, proposed indication, establishment information, and more.
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FDA Approval is Required by Law Federal law requires all new drugs in the U.S. be shown to be safe and effective for their intended use prior to marketing. However, some drugs are available in the U.S. even though they have never received the required FDA approval.
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Most direct additives are identified on the ingredient label of foods. Under the Federal Food, Drug, and Cosmetic Act, a food additive must be authorized by the FDA before it can be used in food on the market.
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The FDA has established several programs to help manufacturers demonstrate with reasonable certainty that a chemical is not harmful when used as proposed. These include: Food additives and color additives: Food additives and color additives require pre-market review and approval by the FDA.
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