Benefitrisk Samenvattingen, Notities en Examens

RAC Chapter 14N (11)- Prescription Drug Product Submission Questions and Answers What act/amendments regulates drugs? ANSWER Drugs are regulated under the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act) and its subsequent amendments. A drug is broadly defined as? ANSWER • any product (or any component of such product) that is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man • a product (other than food), or a component of a product...

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