The federal Food, Drug, and Cosmetic Act requires a new drug to be approved by the Food and Drug Administration (FDA) before it may be legally introduced in interstate commerce. The regulations apply to drug products manufactured domestically and those imported into the United States. To gain approval for marketing, a drug's sponsor (e.g., a pharmaceutical company):
a) Must provide free samples to healthcare providers
b) Must obtain approval from the World Health Organization (WHO)
c) Must conduct clinical trials in at least five countries
d) Must submit a New Drug Application (NDA) to the FDA