True or False: Pre-1938 Drugs do not need the requirements for marketing drug products (i.e. NDA, ANDA, SNDA)
True
True.
Prior to the enactment of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938, there were no requirements for pre-market approval of drug products by the Food and Drug Administration (FDA). Therefore, drugs marketed before 1938, also known as grandfathered drugs, do not need to meet the same requirements for marketing approval as drugs approved after 1938.
However, it’s important to note that these grandfathered drugs are not exempt from FDA regulations entirely. They still must comply with other FDA requirements, such as proper labeling and adherence to current good manufacturing practices (cGMPs).
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