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Frequently Asked Questions
FDA oversees over 6,700 different medical device product categories. There are over 1,600 FDA-approved animal drug products. There are about 621 FDA-licensed biologics products.What does the FDA require before releasing a new drug?
The FDA requires the following sequence of events before approving a drug. Preclinical Testing: A pharmaceutical company conducts certain studies before the future drug is ever given to a human being. Laboratory and animal studies must be done to demonstrate the biological activity of the drug against the targeted disease.Does FDA approval mean that a drug is safe?
“FDA approval is based on evidence — provided by the company that makes the medical product — that the benefits of the product outweigh the risks for most patients for a specific use. It doesn’t necessarily mean the product is safe.” A new drug takes several steps before it makes its way into a consumer’s medicine cabinet.Which products need FDA approval?
New food products which do not contain new additives / new food sourcesCompounded drugsCosmeticsInfant formulas (must meet nutritional requirements/be registered)Food labels (however, food labels must include the Nutrition Facts panel per FDA regulations).